Materials and Methods

In 1996–2000, 319 women from 11 gynecological departments in Denmark were randomized to SAH vs TAH. Details about eligibility criteria, consent, inclusion, randomization, and surgical procedures have been published. The sample size of the original trial was calculated based on an assumed prevalence of the primary outcome, UI, 1 year after TAH of approximately 23%. With a power of 0.80, a type I error of 5%, and a 15% absolute difference in UI between the surgical groups, 160 participants had to be included in each intervention group.

Results from 1 year of follow-up showed that significantly more women in the SAH group were urinary incontinent compared with the TAH group. A decrease in UI after hysterectomy was seen in both surgical groups. The secondary outcomes postoperative complications, quality of life (Short Form-36 [SF-36]), constipation, pelvic organ prolapse, satisfaction with sexual life, and pelvic pain did not show any difference between surgical groups. Neither did the further analyses of lower urinary tract symptoms and sexuality. At 1 year, 20% of the SAH group still experienced vaginal bleeding. At 5 years, the significant difference between SAH and TAH regarding UI was reproduced. The number of incontinent women was higher than at 1 year. In the SAH group, 11% still experienced vaginal bleeding.

All participants still alive and living in Denmark in September 2012 were contacted by letter, and it contained the validated questionnaire ( Appendix; Supplemental Material ) used in prior follow-ups. The questionnaire assessed primary and secondary outcomes (presented in the following text). Reminders were sent 2 and 7 months later to nonresponders. Participants were encouraged to return the questionnaire unanswered if they did not wish to participate, thus avoiding reminders. Age at follow-up and follow-up time was calculated with January 2013 as the cutoff point.

The primary outcome, UI, was defined as a subjective complaint of involuntary loss of urine often or always (question 35 in the questionnaire). Because this result could reflect a difference in treatment-seeking behavior between surgical groups rather than in the occurrence of UI, we also analyzed the number of women who reported UI at any time since hysterectomy including prior follow-ups.

Secondary outcomes were hospital contacts, pelvic organ prolapse (POP), pelvic pain, satisfaction with sex life, constipation, quality of life (QoL), and vaginal bleeding after SAH. All outcomes, except QoL, were dichotomized, and the SAH and TAH groups were compared using a χ ² test. Analyses were conducted as intention to treat as well as per protocol excluding participants that did not receive the allocated intervention ( Figure 1 ). As in prior follow-ups, the conclusions are based on the intention-to-treat analyses. Additionally, satisfaction with sex life was analyzed separately for those stating they had a partner and those who did not.

Flowchart of participants

The figure shows participants at each stage of the trial from randomization through all follow-ups and reasons for dropouts.

SAH , subtotal abdominal hysterectomy; TAH , total abdominal hysterectomy.

Andersen. SAH vs TAH, RCT with 14 year follow-up. Am J Obstet Gynecol 2015 .

QoL was assessed by the validated SF-36 questionnaire included in our questionnaire ( Supplemental Material ). SF-36 was scored according to the specifications by Quality Metric using the official scoring software. For each participant a physical component score (PCS) and a mental component score (MCS) were calculated. These scores are validated and a norms based mean of 50 is interpreted as average QoL. Means were compared between surgical groups using the Wilcoxon rank sum test because the scores were not normally distributed.

Some women did not answer all questions resulting in different totals for each analysis. The number in each group for the particular analysis is stated in Table 1 . To account for possible bias caused by missing data because of the loss to follow-up and incomplete questionnaires, multiple imputation (MI) was carried out using the FCS method in SAS (version 9.3; SAS Institute, Cary, NC) using the PROC MI and MIANALYZE functions. The 14-year outcomes imputed were UI, pelvic pain, POP, satisfaction with sex life, QoL, and constipation.

The following variables were included in the imputation model because they were associated with ( P < .1) one or more of the outcomes in the multivariate logistic regression: baseline variables included type of surgery, number of deliveries, largest baby greater than 4000 g, smoking more than 5 cigarettes per day, alcohol consumption greater than 14 units per week (1 unit = 12 g of alcohol), UI, pain, and constipation. Follow-up variables included were as follows: UI, pelvic pain, POP, constipation, satisfaction with sex life at 1 and 5 years, and physical (PCS) and mental (MCS) QoL scores at 1 year.

One hundred imputed datasets were created using a maximum of 100 iterations. This was chosen to obtain high precision in the analyses. The MI method assumes that missingness is missing at random, meaning that missing data are related to other observed variables but not to unobserved variables or to the missing items. The imputed datasets were analyzed by a χ ² test, and the pooled analyses were carried out using the MIANALYZE function (SAS Institute). Relative risks were logarithmically transformed before pooling to comply with Rubin’s rules for pooling imputed results. The QoL scores were not normally distributed, and despite using the transformations of inverse, log, squared, gamma, exponential, box cox, and beta, we could not approximate the normality. We entered the untransformed scores in the MI model and analyzed them using the Wilcoxon rank sum test. Because a normal distribution is assumed in MI, this could potentially skew other outcomes. However, we ran the MI with and without QoL included, and it had no impact on other outcomes.

Hospital contacts were registered for all randomized women by looking up all discharge summaries from Danish public hospitals from 5 years postoperatively until July 2013 in the central registry of discharge summaries. Any hospital contact regarding abdominal, gynecological, urological (including UI), plastic surgical, or dermatological complaints were scrutinized. If the contact might be related to the prior hysterectomy, it was registered. Hospital contacts from the time of surgery until 5 years postoperatively have been published elsewhere. Hospital contacts were divided into the following categories: recurrent urinary tract infection (including pyelonephritis), pain, UI, POP, cervical problems (bleeding or dysplasia), other urogenital, skin problems/hernias, and others.

All data were handled and analyzed using SASjmp version 10 statistical software (SAS Institute) except for MI, which was carried out in SAS version 9.3 (SAS Institute).

The original trial as well as this follow-up was accepted by the regional ethics committee journal number, SJ-268, as well as the Danish Data Protection Agency journal number 2012-41-0286.

Results

We contacted 304 women (95.3%) (SAH: 153; TAH: 151); 10 (3.1%) had died, from causes unrelated to hysterectomy, and 5 (1.6%) had left Denmark. Two hundred forty-nine women (82%) returned the questionnaire; however, 52 (17.1%) returned it blank stating that they did not wish to participate. A total of 197 (64.8%) answered the questionnaire ( Figure 1 ).

The number of participants in the groups was similar: 97 of 153 (63.4%) in the SAH group and 100 of 151 (66.2%) in the TAH group. Characteristics of the participants and nonparticipants in this follow-up ( Table 2 ) did not differ according to baseline variables from time of surgery except that fewer of the participants were smokers at the time of surgery and more participants had an alcohol consumption greater than 14 units per week at time of surgery than the nonparticipants. The 2 surgical groups of responders were comparable ( Table 2 ). Mean age at follow-up was 60.1 years; mean follow-up time was 14.1 years.

More women in the SAH group (32 of 97, 33.3%) than in the TAH group (20 of 100, 20%) reported UI often or always ( P = .035) ( Table 1 ). The difference was also significant in the per-protocol analysis ( P = .024) ( Table 3 ). Table 3 also shows the other analyses of UI as described in the Materials and Methods section.

Analysis of multiple imputed data showed no significant differences between surgical groups regarding UI ( P = .19) ( Table 1 ).

Neither the physical (PCS) nor the mental (MCS) score of the SF-36 QoL questionnaire differed between the surgical groups, and the means were consistent with the expected mean of 50 ( Table 1 ). None of the participants experienced vaginal bleeding at 14 years.

Twenty-one women (11.5%) stated they did not have a partner. Of these, 9 (42.9%) stated that they did not know whether they were satisfied with their sex life. Six (28.6%) stated they were satisfied and 6 (28.6%) stated they were not. Among those with a partner (n = 162, 88.5%), 22 (13.6%) did not know whether they were satisfied with their sex life, 94 (58%) were satisfied, and 46 (28.4%) were not. Those who stated they did not know whether they were satisfied were excluded from the analysis of satisfaction with sex life in the 2 surgical groups ( Table 1 ). There was no difference in satisfaction with sex life between SAH and TAH overall ( Table 1 ) or when subdivided according to partner status (data not shown). The other secondary outcomes are shown in Table 1 . None of them showed significant differences between surgical groups in the analysis of observed data or in multiple imputation.

Hospital contacts from 5 to 14 years after hysterectomy are shown in Figure 2 . There was no significant difference in the total number of hospital contacts (SAH, 29 [17.7%] vs TAH, 18 [11.3%]; relative risk, 1.57; 95% confidence interval, 0.91–2.71; P = .10).

Hospital contacts from 5 to 14 years after hysterectomy

Bar chart of hospital contacts possibly related to the prior hysterectomy. Contacts are divided into categories and are shown for each hysterectomy group separately.

UTI , urinary tract infection.

Andersen. SAH vs TAH, RCT with 14 year follow-up. Am J Obstet Gynecol 2015 .

Results

We contacted 304 women (95.3%) (SAH: 153; TAH: 151); 10 (3.1%) had died, from causes unrelated to hysterectomy, and 5 (1.6%) had left Denmark. Two hundred forty-nine women (82%) returned the questionnaire; however, 52 (17.1%) returned it blank stating that they did not wish to participate. A total of 197 (64.8%) answered the questionnaire ( Figure 1 ).

The number of participants in the groups was similar: 97 of 153 (63.4%) in the SAH group and 100 of 151 (66.2%) in the TAH group. Characteristics of the participants and nonparticipants in this follow-up ( Table 2 ) did not differ according to baseline variables from time of surgery except that fewer of the participants were smokers at the time of surgery and more participants had an alcohol consumption greater than 14 units per week at time of surgery than the nonparticipants. The 2 surgical groups of responders were comparable ( Table 2 ). Mean age at follow-up was 60.1 years; mean follow-up time was 14.1 years.

Table 1

Primary and secondary outcome measures at 14 year follow-up intention-to-treat

Outcome (n = SAH/TAH)	SAH	TAH	Observed data			Multiple imputation
			RR	95% CI	P value	RR	95% CI	P value
UI, % (n = 96/100)	32 (33.3)	20 (20)	1.67	1.02–2.70	.035 a	1.36	0.86–2.13	.19
Constipation, % (n = 97/100)	14 (14.4)	7 (7)	2.06	0.87–4.89	.091	1.77	0.83–3.77	.14
Pelvic organ prolapse, % (n = 93/97)	12 (12.9)	11 (11.3)	1.14	0.53–2.45	.74	0.97	0.50–1.86	.92
Satisfied with sexual life, % (n = 75/78)	48 (64)	53 (67.9)	0.94	0.75–1.18	.61	1.09	0.76–1.58	.64
Pelvic pain, % (n = 96/100)	14 (14.6)	10 (10)	1.46	0.68–3.12	.33	1.33	0.69–2.55	.40
Vaginal bleeding, % (SAH only, n = 97)	0
QoL b						Mean (95% CI) SAH	Mean (95% CI) TAH
PCS mean (95% CI)	50.4 (48.5–52.4)	51.3 (49.4–53.2)			.54	50.05 (48.5–51.6)	50.9 (49.1–52.8)	.67
MCS mean (95% CI)	54.8 (52.9–56.7)	53.2 (51.4–55.1)			.39	54.4 (52.5–56.1)	52.2 (50.7–54.2)	.87

Only gold members can continue reading. Log In or Register to continue

Share this:

• Click to share on Twitter (Opens in new window)
• Click to share on Facebook (Opens in new window)

Related

Related posts:

1. New kinds of injustice for women?
2. Cost-utility comparison of neoadjuvant chemotherapy versus primary debulking surgery for treatment of advanced-stage ovarian cancer in patients 65 years old or older
3. Recurrence of high-grade cervical abnormalities following conservative management of cervical intraepithelial neoplasia grade 2
4. Investigating racial differences in risk factors for primary cesarean delivery

Stay updated, free articles. Join our Telegram channel

Join