Surgery for Constipation

(PROD Trial)

Recruiting at 1 trial location

Overseen By Jungeun (Camilla) Lee, MS

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: NorthShore University HealthSystem

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

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

Duration: Surgical procedure

120 Participants Needed

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. ^{1 2 3 4 5}

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. ^{1 4 5 6 7}

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. ^{6 8 9 10 11}

Research Team

Ghazaleh Rostami Nia, MD

Principal Investigator

Endeavor Health

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.

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)

Treatment Details

Interventions

• Laparoscopic abdominal ventral rectopexy
• Transvaginal sacrospinous rectopexy

Trial Overview 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.

Participant Groups

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

Who Is Running the Clinical Trial?

NorthShore University HealthSystem

Lead Sponsor

Trials

134

Recruited

740,000+

Endeavor Health

Lead Sponsor

Trials

135

Recruited

742,000+

Weill Medical College of Cornell University

Collaborator

Trials

1,103

Recruited

1,157,000+

University of Pittsburgh

Collaborator

Trials

1,820

Recruited

16,360,000+

Findings from Research

Laparoscopic ventral mesh rectopexy (LVMR) for treating full thickness external rectal prolapse (ERP) shows low complication rates, with only 1% mortality, 3% recurrence, and 3.7% mesh-related complications over a median follow-up of 29 months.

Patients experienced significant improvements in quality of life and bowel function, with a 46% enhancement in quality of life scores sustained for at least 4 years, and high satisfaction ratings averaging 9.1 out of 10.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcome of laparoscopic ventral mesh rectopexy for external rectal prolapse. Randall, J., Smyth, E., McCarthy, K., et al.[2019]

The study provides the first randomized trial evidence showing that laparoscopic ventral mesh rectopexy (LVMR) significantly improves quality of life and symptoms related to defecatory disorders in patients with internal rectal prolapse, with notable improvements observed at 24 weeks post-surgery.

Despite challenges in recruitment, the results indicate that LVMR leads to sustained improvements in patient-reported outcomes, particularly in PAC-QOL and PAC-SYM scores, suggesting its efficacy as a treatment option for this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stepped-wedge randomized controlled trial of laparoscopic ventral mesh rectopexy in adults with chronic constipation. Grossi, U., Lacy-Colson, J., Brown, SR., et al.[2022]

Laparoscopic ventral mesh rectopexy (LVMR) is a safe and effective treatment for full-thickness external rectal prolapse, showing a low recurrence rate of 2.8% and a complication rate of 12.4% across 17 studies involving 1242 patients.

Factors such as male gender and the length of the mesh used during the procedure are associated with higher recurrence rates, suggesting that these elements should be considered when planning LVMR for patients.

NCBI (Pubmed)

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. Emile, SH., Elfeki, H., Shalaby, M., et al.[2020]

Laparoscopic ventral mesh rectopexy (LVMR) using Permacol mesh is a safe and effective treatment for conditions like obstructive defecation and faecal incontinence, with significant improvements in Wexner scores for both constipation and incontinence after surgery.

In a study of 86 patients, only 4.6% experienced recurrences, and there were no reported complications related to the mesh or any mortalities, indicating a favorable safety profile for this procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mesh safety in pelvic surgery: Our experience and outcome of biological mesh used in laparoscopic ventral mesh rectopexy. Tsiaousidou, A., MacDonald, L., Shalli, K.[2022]

Laparoscopic ventral mesh rectopexy (LVMR) using Permacol™ mesh demonstrated low complication rates (10.7%) and no mortality in a study of 224 patients over an 8-year period, indicating it is a safe surgical option for pelvic organ prolapse.

Patients reported significant improvements in functional outcomes related to constipation and faecal incontinence, as well as overall quality of life, with over 90% satisfaction during follow-up, highlighting the efficacy of LVMR in treating these conditions.

NCBI (Pubmed)

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. McLean, R., Kipling, M., Musgrave, E., et al.[2019]

Laparoscopic ventral mesh rectopexy using biological mesh is a safe and effective procedure for treating internal rectal prolapse, with a low conversion rate to open surgery (3%) and an overall complication rate of 23.5%.

Patients showed significant improvement in bowel function, with reductions in constipation and faecal incontinence scores at 3 months post-surgery, and no new-onset constipation or sexual dysfunction reported.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Laparoscopic ventral rectopexy for internal rectal prolapse using biological mesh: postoperative and short-term functional results. Sileri, P., Franceschilli, L., de Luca, E., et al.[2021]

In a long-term follow-up study of 69 patients, laparoscopic ventral mesh rectopexy (LVMR) showed significantly better quality of life and symptom scores related to constipation compared to laparoscopic posterior sutured rectopexy (LPSR) after a median follow-up of 6.1 years.

LVMR also had a lower recurrence rate of rectal prolapse (8.82%) compared to LPSR (23.33%), suggesting it may be a more effective surgical option for long-term management of rectal prolapse.

NCBI (Pubmed)

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. Hidaka, J., Elfeki, H., Duelund-Jakobsen, J., et al.[2022]

Surgical options for pelvic floor dysfunction, including incontinence and constipation, vary in effectiveness, with dorsal and ventral mesh rectopexy showing comparable improvements in incontinence, while ventral rectopexy and resection rectopexy are more effective for constipation.

Suture rectopexy alone is less effective than other surgical procedures, highlighting the importance of choosing the right surgical approach based on specific symptoms and outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Transabdominal procedures for functional bowel diseases]. Kienle, P., Horisberger, K.[2021]

The abdominal Orr-Loygue ventral rectopexy technique, which preserves lateral rectal ligaments, is a safe and effective treatment for total rectal prolapse, showing a low recurrence rate of only 4.1% over an average follow-up of 28.6 months.

This procedure resulted in high patient satisfaction, with 61.6% of patients cured and only a small percentage (5.5%) experiencing new postoperative constipation, suggesting that preserving ligaments helps prevent constipation without increasing recurrence risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Surgery for rectal prolapse: Orr-Loygue ventral rectopexy with limited dissection prevents postoperative-induced constipation without increasing recurrence. Portier, G., Iovino, F., Lazorthes, F.[2006]

Laparoscopic ventral rectopexy for rectal prolapse showed a very low recurrence rate of only 2% and low morbidity (17%) with no reported mortality, making it a safe option for patients, including those over 80 years old.

The procedure significantly improved constipation in 72% of patients and incontinence in 83%, with these benefits maintained over a median follow-up of 24 months, suggesting it may be more effective than traditional posterior rectopexy in preventing postoperative constipation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Laparoscopic ventral rectopexy for external rectal prolapse improves constipation and avoids de novo constipation. Boons, P., Collinson, R., Cunningham, C., et al.[2022]

Ventral rectopexy is an effective surgical procedure for treating full-thickness rectal prolapse, demonstrating low recurrence rates and few complications.

Patients undergoing ventral rectopexy experience significant improvements in symptoms of constipation and fecal incontinence, highlighting its efficacy in enhancing quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ventral rectopexy for rectal prolapse and obstructed defecation. Cullen, J., Rosselli, JM., Gurland, BH.[2021]

References

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

Outcome of laparoscopic ventral mesh rectopexy for external rectal prolapse. [2019]

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

Stepped-wedge randomized controlled trial of laparoscopic ventral mesh rectopexy in adults with chronic constipation. [2022]

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]

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]

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]

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]

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]

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

[Transabdominal procedures for functional bowel diseases]. [2021]

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]

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

Laparoscopic ventral rectopexy for external rectal prolapse improves constipation and avoids de novo constipation. [2022]

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

Ventral rectopexy for rectal prolapse and obstructed defecation. [2021]