Prospective Randomized Controlled Trial of Obstructed Defecation Surgery (PROD)

Endeavor Health

Status: Terminated

Conditions: Obstructed Defecation; Pelvic Organ Prolapse

Treatments: Procedure: Transvaginal sacrospinous rectopexy; Procedure: Laparoscopic abdominal ventral rectopexy

Study type: Interventional

Funder types: Other

Identifiers

NCT05747027

EH22-284

Details and patient eligibility

About

Obstructive defecatory syndrome (ODS) or inability to completely empty bowel is characterized by a combination of straining, incomplete evacuation, and the use of digital manipulation with bowel movement. This is a common condition with estimated incidence of 15-20% in the adult female population.

Laparoscopic abdominal ventral rectopexy is an established surgical technique aimed at restoring rectal support in women with this condition. It is the most common surgery used nowadays to treat ODS. Transvaginal sacrospinous rectopexy, is an innovative procedure which has been shown to be safe and effective in the treatment of stool entrapment. Currently it is unknown whether one of the procedures mentioned is superior to the other regarding surgical outcomes and patient experience. The purpose of this research is to compare the outcomes of these two procedures considering their efficacy to improve symptoms.

During the study, participants will be randomized to undergo one of two procedures for treatment of inability to completely empty their bowel and/or rectal prolapse: 1) laparoscopic abdominal ventral rectopexy; 2) transvaginal sacrospinous rectopexy. Following the procedure, participants will be asked to return to the office for a follow-up visit 2-weeks, 2-, 12- and 24-months after the surgery. During each follow-up visit participants will undergo symptom evaluation, pelvic exam and transvaginal pelvic ultrasound to evaluate surgical success.

Enrollment: 15 patients

Sex: Female

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Female, between the age of 18 and 80

2. OD symptoms as indicated by an affirmative response to either questions 7, 8 or 14 of the Pelvic Floor Distress Inventory (PFDI):

   1. Do you feel you need to strain too hard to have a bowel movement?
   2. Do you feel you have not completely emptied your bowels at the end of a bowel movement?
   3. Does part of your bowel ever pass through the rectum and bulge outside during or after a bowel movement?

3. Rectal hypermobility defined as a compression ratio greater than 50% according to ultrasound

4. Patient planning on undergoing surgery for the repair of pelvic organ prolapse within the next 12 months

5. Patient who is not pregnant and does not intend to become pregnant in the next 2 years

6. Available for 24-months of follow-up

7. Stated willingness to comply with all study procedures and availability for the duration of the study

8. Able to complete study assessments, per clinician judgment

9. Able and willing to provide independent written informed consent

10. Stable cardiovascular and respiratory status to meet candidacy in vaginal or laparoscopic surgeries

Exclusion criteria

1. Contraindication to abdominal and transvaginal rectopexy in the opinion of the treating surgeon
2. History of previous surgery that included any type of surgery for rectal prolapse
3. Pelvic pain or dyspareunia due to levator ani spasm that would preclude a PMT program
4. Previous adverse reaction to synthetic mesh
5. Current cytotoxic chemotherapy or current or history of pelvic radiation therapy within 12 months
6. History of two inpatient hospitalizations for medical comorbidities in the previous 12 months

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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15 participants in 2 patient groups

Laparoscopic abdominal ventral rectopexy

Experimental group

Treatment:

Procedure: Laparoscopic abdominal ventral rectopexy

Transvaginal sacrospinous rectopexy

Experimental group

Treatment:

Procedure: Transvaginal sacrospinous rectopexy