Trial Outcomes & Findings for Bowel Function After Minimally Invasive Hysterectomy (NCT NCT04263896)

Last Updated: 2025-08-19

Results Overview

Constipation will be evaluated both preoperatively and postoperatively using a validated questionnaires (PAC-SYM/PAC-QOL). Patient assessment of constipation symptoms (PAC-SYM) - The Patient Assessment of Constipation-Symptoms (PAC-SYM) questionnaire, developed through psychometric evaluation of adults with chronic constipation, is a tool for assessing the severity of patient-reported symptoms of this disorder. The 12-item questionnaire is divided into three symptom subscales: abdominal (four items); rectal (three items); and stool (five items). Items are scored on 5-point Likert scales, with scores ranging from 0 to 4 (0 = 'symptom absent', 1 = 'mild', 2 = 'moderate', 3 = 'severe' and 4 = 'very severe'). A mean total score in the range of 0-4 is generated by dividing the total score by the number of questions completed; the lower the total score, the lower the symptom burden.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

97 participants

Primary outcome timeframe

change in score from 10 days pre-operation to 7 days post-operation

Results posted on

2025-08-19

Participant Flow

Participant milestones

Participant milestones
Measure	Participants Receiving Pre-operative Laxative Participants will receive 10 doses, 17g each, of polyethylene glycol 3350. They will be instructed to take 1 dose/packet each day for 10 days leading up to their surgery.	Participants Not Receiving Pre-operative Laxative Participants will not be given any laxatives prophylactically, and will follow all standard of care pre-surgical instructions
Overall Study STARTED	50	47
Overall Study COMPLETED	33	28
Overall Study NOT COMPLETED	17	19

Reasons for withdrawal

Reasons for withdrawal
Measure	Participants Receiving Pre-operative Laxative Participants will receive 10 doses, 17g each, of polyethylene glycol 3350. They will be instructed to take 1 dose/packet each day for 10 days leading up to their surgery.	Participants Not Receiving Pre-operative Laxative Participants will not be given any laxatives prophylactically, and will follow all standard of care pre-surgical instructions
Overall Study Withdrawal by Subject	2	4
Overall Study converted to open procedure	0	1
Overall Study Lost to Follow-up	9	11
Overall Study surveys lost in mail	5	3
Overall Study excluded from analysis	1	0

Baseline Characteristics

Bowel Function After Minimally Invasive Hysterectomy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Participants Receiving Pre-operative Laxative n=33 Participants Participants will receive 10 doses, 17g each, of polyethylene glycol 3350. They will be instructed to take 1 dose/packet each day for 10 days leading up to their surgery.	Participants Not Receiving Pre-operative Laxative n=28 Participants Participants will not be given any pre-operative laxatives either through the study or through standard of care.	Total n=61 Participants Total of all reporting groups
Age, Continuous	44 year STANDARD_DEVIATION 10.4 • n=93 Participants	48.1 year STANDARD_DEVIATION 10 • n=4 Participants	46 year STANDARD_DEVIATION 10.4 • n=27 Participants
Sex: Female, Male Female	33 Participants n=93 Participants	28 Participants n=4 Participants	61 Participants n=27 Participants
Sex: Female, Male Male	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=93 Participants	2 Participants n=4 Participants	5 Participants n=27 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	29 Participants n=93 Participants	26 Participants n=4 Participants	55 Participants n=27 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=93 Participants	0 Participants n=4 Participants	1 Participants n=27 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Asian	1 Participants n=93 Participants	0 Participants n=4 Participants	1 Participants n=27 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Black or African American	9 Participants n=93 Participants	9 Participants n=4 Participants	18 Participants n=27 Participants
Race (NIH/OMB) White	19 Participants n=93 Participants	19 Participants n=4 Participants	38 Participants n=27 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Unknown or Not Reported	4 Participants n=93 Participants	0 Participants n=4 Participants	4 Participants n=27 Participants

PRIMARY outcome

Timeframe: change in score from 10 days pre-operation to 7 days post-operation

Outcome measures

Outcome measures
Measure	Participants Receiving Pre-operative Laxative n=24 Participants Participants will receive 10 doses, 17g each, of polyethylene glycol 3350. They will be instructed to take 1 dose/packet each day for 10 days leading up to their surgery.	Participants Not Receiving Pre-operative Laxative n=27 Participants Participants will not be given any laxatives.
Patient Assessment of Constipation Symptoms Questionnaire (PAC-SYM) Score	1.1 score Standard Deviation 0.7	0.6 score Standard Deviation 0.6

PRIMARY outcome

Timeframe: change in score from 10 days pre-operation to 7 days post-operation

Patient assessment of constipation quality of life (PAC-QOL) - PAC-Qol is a self-reported questionnaire, was used to measure the quality of life of patients.9 The validated PAC-QoL is composed of 28 items grouped into four subscales: physical discomfort, psychosocial discomfort, worries and concerns, and satisfaction. The first three subscales are used to assess the patient dissatisfaction index, with an overall score ranging from 0 to 96 (where lower scores correspond to better quality of life). The satisfaction subscale includes four items with a global score ranging from 0 to 16, so that each patient's self-reported definitive outcome is defined as either poor (0-4), fairly good (5-8), good (9-12), or excellent (13-16).

Outcome measures

Outcome measures
Measure	Participants Receiving Pre-operative Laxative n=23 Participants Participants will receive 10 doses, 17g each, of polyethylene glycol 3350. They will be instructed to take 1 dose/packet each day for 10 days leading up to their surgery.	Participants Not Receiving Pre-operative Laxative n=27 Participants Participants will not be given any laxatives.
Patient Assessment of Constipation Quality of Life Questionnaire (PAC-QOL) Score Satisfaction	8.4 score Standard Deviation 4.7	10 score Standard Deviation 4.2
Patient Assessment of Constipation Quality of Life Questionnaire (PAC-QOL) Score Dissatisfaction	21.6 score Standard Deviation 19.7	16.5 score Standard Deviation 14.9

SECONDARY outcome

Timeframe: The 7 days after surgery (surgery is D0)

Visual analog scale - The visual analog scale (VAS) is a measure of subjective pain intensity. It is a continuous scale comprised of a horizontal visual analog scale that is 100 mm in length. The subject will place a mark on the scale to indicate the intensity of her pain. 0 mm would be no pain, 100 mm would be the greatest imaginable pain. Any mark in between will be measured in mm to indicate degree of pain the subject is experiencing.

Outcome measures

Outcome measures
Measure	Participants Receiving Pre-operative Laxative n=33 Participants Participants will receive 10 doses, 17g each, of polyethylene glycol 3350. They will be instructed to take 1 dose/packet each day for 10 days leading up to their surgery.	Participants Not Receiving Pre-operative Laxative n=28 Participants Participants will not be given any laxatives.
Visual Analog Scale for Pain Management Day 1	5.807692 score Standard Deviation 2.112235	5.934615 score Standard Deviation 2.158507
Visual Analog Scale for Pain Management day 2	5.114815 score Standard Deviation 1.886736	5.516 score Standard Deviation 1.993517
Visual Analog Scale for Pain Management Day 3	4.572 score Standard Deviation 1.943691	4.681481 score Standard Deviation 2.068451
Visual Analog Scale for Pain Management Day 4	3.919231 score Standard Deviation 2.234461	3.91 score Standard Deviation 1.659694
Visual Analog Scale for Pain Management Day 5	3.580769 score Standard Deviation 2.249092	3.902692 score Standard Deviation 2.076619
Visual Analog Scale for Pain Management Day 6	3.494 score Standard Deviation 2.386434	3.193478 score Standard Deviation 1.949843
Visual Analog Scale for Pain Management Day 7	3.1044 score Standard Deviation 2.345364	3.153846 score Standard Deviation 2.423919

SECONDARY outcome

Timeframe: The 7 days after surgery (surgery is D0)

Dosages of pain medication consumption will be collected for up to 7 days post-surgery.

Outcome measures

Outcome measures
Measure	Participants Receiving Pre-operative Laxative n=33 Participants Participants will receive 10 doses, 17g each, of polyethylene glycol 3350. They will be instructed to take 1 dose/packet each day for 10 days leading up to their surgery.	Participants Not Receiving Pre-operative Laxative n=28 Participants Participants will not be given any laxatives.
Pain Medication Consumption Tracking by Participant day 1	11.82692 morphine milligram equivalents Standard Deviation 8.903867	14.33333 morphine milligram equivalents Standard Deviation 13.11312
Pain Medication Consumption Tracking by Participant day 2	8.981481 morphine milligram equivalents Standard Deviation 9.982178	12.58333 morphine milligram equivalents Standard Deviation 15.51533
Pain Medication Consumption Tracking by Participant Day 3	7.410714 morphine milligram equivalents Standard Deviation 9.824434	7.758621 morphine milligram equivalents Standard Deviation 12.0702
Pain Medication Consumption Tracking by Participant Day 4	4.017857 morphine milligram equivalents Standard Deviation 9.362536	5 morphine milligram equivalents Standard Deviation 10.48809
Pain Medication Consumption Tracking by Participant Day 5	2.222222 morphine milligram equivalents Standard Deviation 5.814989	2.258065 morphine milligram equivalents Standard Deviation 4.625781
Pain Medication Consumption Tracking by Participant Day 6	1.388889 morphine milligram equivalents Standard Deviation 3.126602	0.8333333 morphine milligram equivalents Standard Deviation 2.653343
Pain Medication Consumption Tracking by Participant Day 7	1.388889 morphine milligram equivalents Standard Deviation 3.126602	0.483871 morphine milligram equivalents Standard Deviation 1.981093

SECONDARY outcome

Timeframe: 7 days before surgery

Wexner a commonly used scoring system, is designed to assess the prevalence and severity of constipation. It is based on pathophysiological definition of constipation. The scoring system is based on eight variables (frequency of bowel movements; difficult or painful evacuation; completeness of evacuation; abdominal pain; time per attempt; type of assistance including laxatives; digitations or enemas; number of unsuccessful attempts at evacuation in a 24-h period and duration of constipation). The CSS consists of seven items that are scored using a five-point Likert scale that ranges from 0 (none of the time) to 4 (all of the time) and one item that is rated on a 0-2 scale. A total score can range from 0 (normal) to 30 (severe constipation). A cutoff score of 15 suggests constipation.

Outcome measures

Outcome measures
Measure	Participants Receiving Pre-operative Laxative n=32 Participants Participants will receive 10 doses, 17g each, of polyethylene glycol 3350. They will be instructed to take 1 dose/packet each day for 10 days leading up to their surgery.	Participants Not Receiving Pre-operative Laxative n=29 Participants Participants will not be given any laxatives.
Wexner/ Constipation Scoring System/1996 Cleveland Clinic Score / Agachan Score	7.3 score Standard Deviation 5	5.6 score Standard Deviation 3.7

Adverse Events

Participants Receiving Pre-operative Laxative

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Participants Not Receiving Pre-operative Laxative

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Sandra Laveaux

University of Chicago

Phone: 773-702-6118

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place