Surgery for Constipation

(PROD Trial)

No longer 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial compares two surgical procedures for women with obstructive defecatory syndrome (ODS), a condition that makes it difficult to fully empty the bowels. The first procedure, laparoscopic abdominal ventral rectopexy, is already widely used. The second is an innovative method called transvaginal sacrospinous rectopexy. The researchers aim to determine which surgery better improves symptoms and overall patient experience. Women who often feel they haven't fully emptied their bowels or experience bowel bulging during bowel movements might be suitable candidates for this study. As an unphased trial, it offers participants the opportunity to contribute to valuable research that could enhance surgical options for ODS.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that both laparoscopic abdominal ventral rectopexy and transvaginal sacrospinous rectopexy are safe options for treating obstructive defecatory syndrome (ODS).

Laparoscopic abdominal ventral rectopexy is a well-established technique with positive long-term results. It prevents new constipation issues and significantly improves symptoms over time. Studies indicate that patients generally tolerate this procedure well.

Transvaginal sacrospinous rectopexy, though newer, is also safe and effective. Research has found it improves symptoms like straining and incomplete emptying. This method is suitable for women undergoing surgery for pelvic organ prolapse, where pelvic organs shift from their normal position.

Both procedures aim to improve bowel function, and studies support their general tolerance and successful outcomes. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments for constipation because they offer minimally invasive surgical options that address the root causes of the condition. Laparoscopic abdominal ventral rectopexy and transvaginal sacrospinous rectopexy are unique because they focus on correcting rectal prolapse, which can be a major underlying issue in chronic constipation. Unlike traditional treatments that often rely on medications or lifestyle changes, these procedures aim to provide a structural solution by supporting and stabilizing the rectum. This can potentially lead to more lasting relief for patients who haven’t responded well to other therapies.

What evidence suggests that this trial's procedures could be effective for treating obstructive defecatory syndrome?

This trial compares the effectiveness of laparoscopic abdominal ventral rectopexy and transvaginal sacrospinous rectopexy for treating obstructive defecatory syndrome (ODS). Research has shown that laparoscopic abdominal ventral rectopexy can improve symptoms like incontinence in 31-84% of patients, with a low recurrence rate of 5-15%. This procedure also provides lasting improvements in symptoms and anatomy. Meanwhile, transvaginal sacrospinous rectopexy, a newer method, has proven safe and effective for treating stool entrapment, with studies showing significant improvement in symptoms of obstructed defecation. Both procedures are well-established options, and current research further compares their effectiveness in this trial. ^{1 2 3 5 6}

Who Is on the Research Team?

Ghazaleh Rostami Nia, MD

Principal Investigator

Endeavor Health

Are You a Good Fit for This Trial?

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

Available for 24-months of follow-up

Timeline for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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 (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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12116917/

Outcomes of laparoscopic ventral mesh rectopexy versus ... Obstructive defecation symptoms and sexual function showed significant improvement after 1 year of follow-up after both techniques.

2. emedicine.medscape.com emedicine.medscape.com/article/1892539-overview

Laparoscopic and Robotic Rectopexy Abdominal rectopexy yields low recurrence rates (5-15%) and achieves improvement of incontinence in 31-84% of patients. However, this approach ...

3. link.springer.com link.springer.com/article/10.1007/s10151-024-03104-0

Long-term outcome of laparoscopic ventral rectopexy for ... LVR for RP is a safe and efficient technique with sustainable long-term results that shows long-term efficacy at > 10 years after the operation.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5017094/

Short term outcome of laparoscopic ventral rectopexy for ... Laparoscopic ventral rectopexy not only reduces the prolapse and corrects the anatomy but also improves the function and the associated symptoms of incontinence ...

5. jogs.org jogs.org/article/S1091-255X(23)03723-X/abstract

Laparoscopic Ventral Rectopexy for Internal Rectal ... Twenty-eight patients (82%) had a constipation score ≥5, while 14 (41%) a FISI score ≥10. Nine patients (26%) had mixed obstructed defaecation and faecal ...

6. thelancet.com thelancet.com/journals/eclinm/article/PIIS2589-5370(19)30158-0/fulltext

Functional Outcome after Laparoscopic Posterior Sutured ... Laparoscopic ventral mesh rectopexy (LVMR) for rectal prolapse has been implemented to reduce postoperative bowel symptoms.