Effect of surgical approach on physical activity and pain control after sacral colpopexy




Objective


We sought to compare recovery of activity and pain control after robotic (ROB) vs abdominal (ABD) sacral colpopexy.


Study Design


Women undergoing ROB and ABD sacral colpopexy wore accelerometers for 7 days preoperatively and the first 10 days postoperatively. They completed postoperative pain diaries and Short Form-36 questionnaires before and after surgery.


Results


At 5 days postoperatively, none of the 14 subjects in the ABD group and 4 of 28 (14.3%) in the ROB group achieved 50% total baseline activity counts ( P = .283). At 10 days, 5 of 14 (35.7%) in the ABD group and 8 of 26 (30.8%) in the ROB group ( P = .972) achieved 50%. Postoperative pain was similar in both groups. Short Form-36 vitality scores were lower ( P = .017) after surgery in the ABD group, but not in the ROB group.


Conclusion


Women undergoing ROB vs ABD sacral colpopexy do not recover physical activity faster, and pain control is not improved.


The most durable surgical treatment for female apical pelvic organ prolapse is the sacral colpopexy, which has traditionally been performed via laparotomy. The short-term morbidity associated with abdominal (ABD) incisions includes pain, infection, and compromised respiratory function. Long-term morbidity includes chronic pain. A recent study of women who underwent Pfannenstiel incision for hysterectomy or cesarean delivery showed that about a third of them had chronic incisional pain after 2 years. This pain was severe enough to impair daily activities in 8.9% of subjects.


During the last 2 decades, sacral colpopexy has become increasingly available through minimally invasive approaches using advanced laparoscopic and robotic (ROB) techniques. While laparoscopic and ROB sacral colpopexies have been shown to incur greater cost and time in the operating room compared with ABD procedures, they lead to shorter postoperative hospitalization and decreased blood loss. Although the additional benefits of decreased postoperative pain and faster return to baseline physical activity with minimally invasive compared to open colpopexy have been widely suspected, more data are needed. The recent finding that ROB sacral colpopexy is more painful than laparoscopic sacral colpopexy casts doubt on the assumption that ROB surgery confers the same patient benefits as laparoscopy when compared with laparotomy.


Several studies from the general surgery literature use quantitative indices of physical activity to demonstrate the benefit of laparoscopy over ABD surgery. Exercise testing is one such method but often requires extra equipment, additional patient visits, and time from trained exercise physiologists. Studies using accelerometers, portable devices that measure motion in 3 dimensions, can avoid some of these operational obstacles. Studies have measured preoperative and postoperative movement with accelerometers to compare recovery after laparoscopic vs ABD procedures and have shown faster recovery after laparoscopic surgery. These devices have been validated for quantifying physical movement and for measuring physical activity in surgical patients.


Several quality-of-life instruments have been used to assess functional status and physical activity in perioperative patients. The Short Form-36 (SF-36) questionnaire is a validated instrument that assesses health and well-being in 8 subscales of human functioning and has been used to track perioperative changes in physical and mental status. It reflects the 4 weeks of the subject’s life prior to the instrument’s completion. Of the 8 subscales, the role-physical (RP) and role-emotional (RE) domains address difficulties accomplishing daily activities. The vitality (VT) domain assesses subjects’ perceived level of energy. The bodily pain subscale measures the presence and impact of physical pain on functioning.


The primary objective of this study was to use accelerometer data to determine whether patients who undergo sacral colpopexy using the ROB approach return to their baseline physical activity sooner than those who undergo sacral colpopexy via laparotomy. There were 2 secondary objectives. The first was to determine whether the SF-36 subjective quality-of-life instrument indicates that subjects who undergo ROB sacral colpopexy have more favorable early postoperative courses than those who undergo traditional ABD sacral colpopexy. The second was to compare postoperative pain control between groups. We hypothesized that both objective accelerometer and subjective SF-36 data would indicate faster early postoperative recovery in the patients who underwent ROB sacral colpopexy compared to traditional ABD sacral colpopexy. We also predicted improved early postoperative pain control in the ROB group.


Materials and Methods


This study was approved by the Hartford Hospital Institutional Review Board. Subjects were women with apical pelvic organ prolapse who were candidates for sacral colpopexy in an academic urogynecology practice of 3 surgeons, all of whom use similar criteria in selecting patients for sacral colpopexy. Generally, candidates have primarily apical and anterior compartment prolapse, are in good health, and wish to maintain the capacity for sexual function. Once sacral colpopexy was selected for treatment, surgical approach was generally decided by the surgeons, who preferentially offered ROB colpopexy in the absence of relative contraindications to this approach. The most common contraindications were medical comorbidities raising concerns about prolonged maximum Trendelenburg position and suspected pelvic adhesive disease conferring a high risk of conversion to laparotomy. Consecutive candidates age >18 years with the ability to understand and comply with instructions for the study were recruited. Women age <18 years and those lacking the mental capacity to comply with study protocol were excluded. Several subjects had concurrent procedures (eg, hysterectomy, anterior repair, midurethral sling) done at the time of sacral colpopexy, but patients who underwent concurrent posterior repair and/or abdominoplasty were excluded. Women unable to complete the SF-36 questionnaire, which is available in English and Spanish, were excluded.


Each eligible woman was mailed a letter describing the study and a copy of the informed consent well in advance of her preoperative visit, where she signed consent if she wanted to participate. Each enrolled subject completed an SF-36 questionnaire and was given an accelerometer (Actical Mini Mitter; Phillips Respironics, Bend, OR) to wear for the following 7 days after the preoperative visit. This device ( Figure 1 ) measures approximately 1.14 × 1.45 × 0.43 in and weighs <1 oz. It affixes to the waistband of each subject’s pants or skirt with a plastic clip. Subjects were instructed on the use of the devices, which were to be worn during waking hours when subjects were wearing clothes to which the devices could be clipped. The devices were to be removed during bathing and sleeping. Subjects were given diaries to record times when they woke up and when they went to sleep. They were also asked to track periods of unusually sedentary or vigorous activity. The devices were collected from the subjects just before their surgeries, and the preoperative data were downloaded. The accelerometers were then reset and returned to the subjects with new diaries in the hospital on the morning of postoperative day 1 by 8:00 am . The accelerometers measured postoperative movement for the following 10 days. Patients also received pain diaries on which to record all episodes of analgesic usage after discharge. They kept track of the severity of pain using a standard visual analog scale (VAS), the date and time of the analgesic usage, the name of the medication taken, and the number of tablets consumed. The accelerometers and diaries were returned either by post with prepaid mailing envelopes or in person at postoperative visits 3-4 weeks after surgery. A second SF-36 questionnaire was administered to each subject at this visit.




FIGURE 1


Accelerometer

Respironics accelerometer records amount and type of movement in units called “counts.” Sleeping or rest constitutes “sedentary” activity. “Light” activity is <3 metabolic equivalents (METs) and consists of activities such as office work. “Moderate” activity is as intense as housework, between 3-6 METs. “Vigorous” activity is exercise and describes work >6 METs in intensity.

Collins. Physical activity, pain, after colpopexy. Am J Obstet Gynecol 2012.


Surgical technique was similar among the 3 participating surgeons. The laparotomy incisions were most often low transverse Pfannenstiel incisions. There were, however, 5 subjects in the ABD group who underwent midline vertical incisions to the level of the umbilicus; concurrent colon and rectal surgery was performed in these cases. All subjects who underwent ROB colpopexy had the following incisions: a 12-mm umbilical incision for the camera port, a right lower quadrant 12-mm laparoscopic incision for the assist port, 2 (bilateral) upper quadrant 8-mm incisions located about 10 cm lateral and 2-3 cm cephalad to the umbilicus for ROB trocars, and a left lower quadrant 8-mm incision for the last ROB trocar.


Postoperatively, subjects were given precautions to avoid the following physical activities: vaginal intercourse for 6-8 weeks, lifting of items >10 lb for 6 weeks, and driving for 10-14 days after surgery. Subjects were advised to resume walking and activities of daily living immediately but to abstain from rigorous exercise until 6 weeks after surgery.


Accelerometer data parameters selected for study include total activity counts (AC) and percentage of time spend in sedentary (%T sed ), light (%T light ), moderate (%T mod ), and vigorous (%T vig ) activity. Preoperative data were selected from 4 days of recorded data with care taken to select a representative set of data, incorporating weekend and work days if possible. The selection of 4 of the 7 days was facilitated by review of the movement diaries collected by the subjects. These 4 days’ data were averaged for each of the 5 parameters above (AC, %T sed , %T light , %T mod , and %T vig ). The postoperative data were analyzed by postoperative day, and each parameter was expressed as a percentage of its preoperative counterpart for each subject. The numbers of subjects who achieved 50% of baseline physical activity in all 5 parameters by postoperative day 5 and postoperative day 10 were compared. The mean percentages of postoperative recovery by day 10 was also calculated for each parameter and compared between groups. Subjects with >3 days of missing postoperative accelerometer data were excluded from activity analysis.


The SF-36 questionnaires were scored for preoperative and postoperative total and subscale scores. The preoperative and postoperative subscale scores for RP, RE, VT, and bodily pain were compared by surgical approach (ROB vs ABD) using the Mann-Whitney U test. These subscales were chosen because they describe physical recovery without requiring subjects to comment on activities they have been instructed to avoid by their surgeons. All subjects who completed preoperative and postoperative SF-36 questionnaires were included in this analysis.


Inpatient pain data were abstracted from the nursing flow sheet in the hospital’s electronic medical record. Nursing protocol on surgical units requires pain assessment of postoperative patients at least once per shift. The Medical Administration Record, also recorded in the electronic medical record, was used to determine the number of oral analgesic doses taken before discharge. Narcotics delivered via patient-controlled analgesia systems and as-needed intravenous bolus doses of narcotic medications were not evaluated. Parameters compared between groups included average VAS score on postoperative day 1, average VAS score on postoperative day 3, number of narcotic tablets taken on postoperative day 3, number of postoperative days on narcotic analgesics, and whether narcotic medications were still being used on postoperative day 10.


This study was powered using data from an accelerometer study by Inoue et al of patients with gastrectomy. The primary outcome was a commonly used measure called “recovery time,” the first postoperative day on which patients accomplished at least 90% of baseline physical activity. Because our practice performs more ROB than open sacral colpopexies, this study was powered for sample sizes to be approximately 60% (ROB) and 40% (ABD). A sample size of 11 in the ABD group and 17 in the ROB group would afford 81% power to detect a difference in means of 2.0 days to recovery (the difference between a mean recovery in the ROB group of 3.0 days and a mean of 5.0 days in the open group), assuming that the common SD is 1.75 days (a large effect size, d, of 1.1), using a 2-group t test with a .05 2-sided significance level. This per-group sample size also would afford 80% power to detect a 25% difference in SF-36 scores between the 2 groups, again assuming a large effect size (d = 1.1). It was estimated that approximately two-thirds of eligible subjects would consent, and that 90% would complete the study. Thus, to enroll and retain the desired number of 28, 48 subjects (29/ROB group [60%] and 19/ABD group [40%]) were recruited.


Descriptive analyses included medians with interquartile ranges and means with SD to summarize continuous data (eg, age, body mass index). Categorical and/or dichotomous variables were summarized with frequencies and expressed as a percentage, with 95% confidence intervals. Continuous data were assessed for normality of distribution, and Fisher exact tests or paired t tests were used to compare accelerometer data between groups as appropriate. Student t test was used to compare differences between groups using normally distributed data, and Mann-Whitney U test was used to compare differences between groups for nonnormally distributed data.


An a priori alpha level of 0.05 was established as the basis for declaring statistical significance; thus, results yielding P < .05 were deemed statistically significant. All analyses used SPSS software (version 19.0; SPSS Inc, Chicago, IL).




Results


A total of 52 subjects were enrolled into the study. Please see Figure 2 for subject flow. Thirty ROB and 18 ABD subjects completed preoperative and postoperative SF-36 questionnaires and are included in the analysis of baseline medical, demographic, and surgical data ( Table 1 ). Subjects were similar with respect to age, body mass index, and history of ABD surgery between groups. Comparable numbers of subjects underwent concurrent hysterectomies and midurethral slings in both groups. Baseline physical activity parameters measured preoperatively also were similar between groups ( Table 2 ). Preoperative and postoperative accelerometer data were available for 28 subjects who underwent ROB sacral colpopexy and 16 who underwent ABD sacral colpopexy.




FIGURE 2


Flow of enrolled subjects through study in abdominal and robotic groups

ABD, abdominal; ROB, robotic.

Collins. Physical activity, pain, after colpopexy. Am J Obstet Gynecol 2012.


TABLE 1

Demographic, medical, and surgical data






















































Variable ABD (n = 18) ROB (n = 30) P value
Age, y (mean ± SD) 57.33 ± 12.64 58.30 ± 7.27 .770 a
BMI (mean ± SD) 28.16 ± 5.01 26.79 ± 5.11 .372 a
Caucasian (n, %) 14/18 (77.8) 28/30 (93.3) .179 b
ASA, median (interquartile range) 2 (2-3) 2 (2-2) .981 c
History of ABD surgery (n, %) 11/18 (61.1) 14/30 (46.7) .383 b
OR time, min (mean ± SD) 245.78 ± 48.89 262.87 ± 51.87 .437 d
EBL, mL (mean ± SD) 215.28 ± 154.14 83.33 ± 47.04 < .001 d
Concurrent hysterectomy (n, %) 15/18 (83.3) 21/30 (70.0) .493 b
Concurrent transobturator sling (n, %) 7/18 (38.9) 9/30 (30.0) .545 b

ABD, abdominal; ASA, American Society of Anesthesiologists classification; BMI, body mass index; EBL, estimated blood loss; OR, operating room; ROB, robotic.

Collins. Physical activity, pain, after colpopexy. Am J Obstet Gynecol 2012.

a Student t test;


b Fisher exact test;


c Median test;


d Mann-Whitney U test.


May 15, 2017 | Posted by in GYNECOLOGY | Comments Off on Effect of surgical approach on physical activity and pain control after sacral colpopexy

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