Surgery for Constipation

(PROD Trial)

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen by Ghazaleh Rostami Nia, MD

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: NorthShore University HealthSystem

Disqualifiers: Previous rectal prolapse surgery, Pelvic pain, Chemotherapy, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

What data supports the effectiveness of the treatment Laparoscopic ventral mesh rectopexy for constipation?

Research shows that laparoscopic ventral mesh rectopexy (LVMR) is effective in treating rectal prolapse, which can be related to constipation. Studies indicate it helps with conditions like obstructive defecation and improves quality of life for patients with pelvic organ prolapse.

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Is laparoscopic ventral mesh rectopexy generally safe for humans?

Laparoscopic ventral mesh rectopexy is considered a safe procedure for treating rectal prolapse and related conditions, with studies showing it does not typically cause new constipation and improves symptoms like obstructive defecation and fecal incontinence.

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How is the treatment for constipation using laparoscopic abdominal ventral rectopexy different from other treatments?

Laparoscopic abdominal ventral rectopexy is unique because it uses a minimally invasive approach with a mesh to support the rectum, improving constipation and avoiding new constipation that can occur with other surgeries. This treatment is particularly effective for rectal prolapse and does not involve extensive dissection, which helps prevent postoperative constipation.

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Eligibility Criteria

This trial is for adult women suffering from obstructive defecatory syndrome (ODS), who often strain, can't fully empty their bowels, or need to manually assist bowel movements. Participants must be able to complete study assessments and provide consent, have rectal hypermobility as shown by ultrasound, and commit to a 24-month follow-up.

Inclusion Criteria

Able to complete study assessments, per clinician judgment

Able and willing to provide written informed consent

My ultrasound shows my rectum moves more than normal.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized to undergo either laparoscopic abdominal ventral rectopexy or transvaginal sacrospinous rectopexy for treatment of obstructive defecatory syndrome

Surgical procedure

1 visit (in-person)

Follow-up

Participants are monitored for surgical success and symptom evaluation through follow-up visits at 2 weeks, 2 months, 12 months, and 24 months post-surgery

24 months

4 visits (in-person)

Participant Groups

The trial compares two surgeries for ODS: laparoscopic abdominal ventral rectopexy and transvaginal sacrospinous rectopexy. Women will be randomly assigned one of these procedures and followed up at intervals over two years to assess symptoms and surgical success.

Group I: Transvaginal sacrospinous rectopexy Experimental Treatment 1 Intervention

Group II: Laparoscopic abdominal ventral rectopexy Experimental Treatment 1 Intervention

Laparoscopic abdominal ventral rectopexy is already approved in European Union, United States for the following indications:

🇪🇺 Approved in European Union as Laparoscopic abdominal ventral rectopexy for:

• Obstructive defecatory syndrome (ODS)
• Rectal prolapse
• Internal rectal prolapse (rectal intussusception)
• Rectocele
• Enterocele
• Mucosal prolapse

🇺🇸 Approved in United States as Laparoscopic abdominal ventral rectopexy for:

• Obstructive defecatory syndrome (ODS)
• Rectal prolapse
• Internal rectal prolapse (rectal intussusception)
• Rectocele
• Enterocele
• Mucosal prolapse

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Endeavor Health Skokie, IL

Weill Cornell Medicine New York, NY

Who Is Running the Clinical Trial?

NorthShore University HealthSystem Lead Sponsor

Endeavor Health Lead Sponsor

Weill Medical College of Cornell University Collaborator

University of Pittsburgh Collaborator

References

1. England pubmed.ncbi.nlm.nih.gov

Outcome of laparoscopic ventral mesh rectopexy for external rectal prolapse. [2019] The study assessed the efficacy of laparoscopic ventral mesh rectopexy (LVMR) for full thickness external rectal prolapse (ERP), including recurrent prolapse.

2. Italy pubmed.ncbi.nlm.nih.gov

Stepped-wedge randomized controlled trial of laparoscopic ventral mesh rectopexy in adults with chronic constipation. [2022] The effectiveness of laparoscopic ventral mesh rectopexy (LVMR) in patients with defecatory disorders secondary to internal rectal prolapse is poorly evidenced. A UK-based multicenter randomized controlled trial was designed to determine the clinical efficacy of LVMR compared to controls at medium-term follow-up.

3. Germany pubmed.ncbi.nlm.nih.gov

Outcome of laparoscopic ventral mesh rectopexy for full-thickness external rectal prolapse: a systematic review, meta-analysis, and meta-regression analysis of the predictors for recurrence. [2020] Laparoscopic ventral mesh rectopexy (LVMR) has proved effective in the treatment of internal and external rectal prolapse. The present meta-analysis aimed to determine the predictive factors of recurrence of full-thickness external rectal prolapse after LVMR.

4. United States pubmed.ncbi.nlm.nih.gov

Mesh safety in pelvic surgery: Our experience and outcome of biological mesh used in laparoscopic ventral mesh rectopexy. [2022] Laparoscopic ventral mesh rectopexy (LVMR) continues to be a popular treatment option for rectal prolapse, obstructive defecation/faecal incontinence and rectoceles. In recent years there have been concerns regarding the safety of mesh placements in the pelvis.

5. England pubmed.ncbi.nlm.nih.gov

Short- and long-term clinical and patient-reported outcomes following laparoscopic ventral mesh rectopexy using biological mesh for pelvic organ prolapse: a prospective cohort study of 224 consecutive patients. [2019] Laparoscopic ventral mesh rectopexy (LVMR) is potentially a safe and effective operation to correct pelvic organ prolapse and to treat obstructive defaecation and solitary rectal ulcer syndrome. This study aimed to evaluate, in a prospective, consecutive cohort of patients, the long-term clinical outcomes following LVMR, patient-reported functional and quality of life outcomes, and urinary and sexual dysfunction.

6. United States pubmed.ncbi.nlm.nih.gov

Laparoscopic ventral rectopexy for internal rectal prolapse using biological mesh: postoperative and short-term functional results. [2021] Laparoscopic ventral mesh rectopexy is a novel procedure to correct internal and external rectal prolapse. Several authors have shown that this approach is safe and improves obstructive defaecation symptoms and faecal incontinence, without inducing new-onset constipation, possible after posterior rectopexy. Over the last decade, as for other procedures, biological meshes are used to correct pelvic floor disorders. Literature data are scant. In this study, we present our experience with this procedure using biological mesh.

7. England pubmed.ncbi.nlm.nih.gov

Functional Outcome after Laparoscopic Posterior Sutured Rectopexy Versus Ventral Mesh Rectopexy for Rectal Prolapse: Six-year Follow-up of a Double-blind, Randomized Single-center Study. [2022] Laparoscopic ventral mesh rectopexy (LVMR) for rectal prolapse has been implemented to reduce postoperative bowel symptoms. The preoperative-to-postoperative change in a double-blinded, randomized study comparing it to laparoscopic posterior sutured rectopexy (LPSR) found no significant difference between the two procedures after one year. The aim of this study was to investigate the long-term functional outcomes.

8. Germany pubmed.ncbi.nlm.nih.gov

[Transabdominal procedures for functional bowel diseases]. [2021] Incontinence and constipation can occur in cases of pelvic floor dysfunction. Purely morphological changes without severe clinical symptoms are not an indication for surgery. Abdominal operations can be classified into procedures with dorsal (with or without bowel resection and with or without mesh implantation) and procedures with ventral rectopexy (with mesh). With respect to constipation and incontinence suture rectopexy alone is inferior to all other procedures. Dorsal and ventral mesh rectopexy and resection rectopexy are all comparable with respect to improvement of incontinence. Ventral rectopexy without dorsal mobilization and resection rectopexy are superior to mesh rectopexy with respect to constipation. Due to poor evidential status treatment is carried out from a pragmatic viewpoint.

9. United States pubmed.ncbi.nlm.nih.gov

Surgery for rectal prolapse: Orr-Loygue ventral rectopexy with limited dissection prevents postoperative-induced constipation without increasing recurrence. [2006] Abdominal rectopexy is the preferred surgical technique for the treatment of total rectal prolapse. In many reported series, its results are impaired by induced constipation. Lateral rectal ligaments preservation could prevent constipation but increase recurrence rates. We report anatomic and functional results of abdominal Orr-Loygue ventral rectopexy with dissection limited to anterior and posterior rectal wall.

10. England pubmed.ncbi.nlm.nih.gov

Laparoscopic ventral rectopexy for external rectal prolapse improves constipation and avoids de novo constipation. [2022] Abdominal rectopexy is ideal for otherwise healthy patients with rectal prolapse because of low recurrence, yet after posterior rectopexy, half of the patients complain of severe constipation. Resection mitigates this dysfunction but risks a pelvic anastomosis. The novel nerve-sparing ventral rectopexy appears to avoid postero-lateral rectal dissection denervation and thus postoperative constipation. We aimed to evaluate our functional results with laparoscopic ventral rectopexy.

11. United States pubmed.ncbi.nlm.nih.gov

Ventral rectopexy for rectal prolapse and obstructed defecation. [2021] Ventral rectopexy has gained popularity in Europe to treat full-thickness rectal external and internal prolapse. This procedure has been shown to achieve acceptable anatomic results with low recurrence rates, few complications, and improvements of both constipation and fecal incontinence. The authors review the principles, techniques, and outcomes of ventral rectopexy.