Posterior LaparoscopicNCT06559085
Posterior Versus Lateral Laparoscopic Mesh Rectopexy for the Management of Complete Rectal Prolapse
A study testing Laproscopic posterior mesh rectopexy (Wells or LPMR) and Laparoscopic lateral mesh rectopexy (Orr-Loygue) in people with Posterior Laparoscopic and Lateral Laparoscopic, run by Assiut University at 1 site in Egypt.
Trial summary
Aim of the study is to evaluate the outcomes of two different methods of mesh placement during laparoscopic rectopexy for the management of complete rectal prolapse lateral versus posterior mesh rectopexy Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Posterior Laparoscopic, Lateral Laparoscopic, Rectopexy
- What is being tested?
- Laproscopic posterior mesh rectopexy (Wells or LPMR) and Laparoscopic lateral mesh rectopexy (Orr-Loygue)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Aug 2024to 1 Oct 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age from 18 to 70 years.
- Both sexes.
- Patients with complete rectal prolapse.
Who cannot join
- Unfit for surgery
- Impaired coagulation profile
- Contraindication of laparoscopy
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Assiut university
Asyut
Omar M Makhlouf, Master, 00201022533837, omarmakhlof1993@gmail.com
Abd El-Moneim I El-Khatib, MD
About this study
Aim of the study is to evaluate the outcomes of two different methods of mesh placement during laparoscopic rectopexy for the management of complete rectal prolapse lateral versus posterior mesh rectopexy
Read the detailed description
Rectal prolapse is the full-thickness prolapse of the rectum, in which the rectum passes externally beyond the anal sphincters. It is a somewhat rare condition, estimated to occur in less than 0.5% of the population. Rectal prolapse has a 9:1 female predominance, and while it is occasionally seen in younger individuals, the incidence increases with age.
Surgical approaches for rectal prolapse can be divided into perineal and abdominal approaches. Traditionally, a perineal procedure such as Delorme or Altemeir operation was commonly used in elderly or frail patients while an abdominal procedure such as rectopexy with or without resection was reserved for younger and fitter patients. The frequency of laparoscopic abdominal repair of rectal prolapse has increased in recent years, with mesh rectopexy being the most popular procedure.
The mesh rectopexy operation was first described by Ripstein10 in 1952. Again, after mobilization of the rectum, an anterior sling of synthetic material (either absorbable or non-absorbable) is placed in front of the rectum and sutured to the sacral promontory. The rationale for this is to restore the natural curve of the rectum, which reduces the effect of downward abdominal pressure. The use of a non-elastic synthetic graft provides a firm anterior fascial support even in patients with significant pelvic floor descent, returning the rectum to a normal anatomical position.
The act of mobilization, suture, and fibrosis keeps the rectum fixed in position as adhesions form, attaching the rectum to the presacral fascia. Although SR is considered a good option for the cure of rectal prolapse/IS in both men and women, some reviews of this procedure noted a better overall clinical outcome in men. This may be due to occult sphincter defects in women, and failure to detect these defects before surgery owing to the lack of routine endoanal ultrasonography in the earlier years of prolapse surgery
- Being tested
- Laproscopic posterior mesh rectopexy (Wells or LPMR), Laparoscopic lateral mesh rectopexy (Orr-Loygue)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laproscopic posterior mesh rectopexy (Wells or LPMR)Procedure or surgery
After complete rectal mobilization, a mesh is inserted between the sacrum and the posterior rectum, sutured into the rectum, and fixed to the promontory. The mortality rates ranged from 0% to 1.2%, and recurrence rates ranged from 0% to 11% There was an overall improvement in continence (74%-100%), with conflicting results regarding constipation. New-onset constipation in 5% to 44% of patients was reported
Laparoscopic lateral mesh rectopexy (Orr-Loygue)Procedure or surgery
This procedure involves complete mobilization of the rectum with two mesh strips sutured laterally to the rectal wall on both sides, and they were suspended to the promontory. There are several studies on this procedure using a laparoscopic approach. Lechaux et al. performed laparoscopic Orr-Loygue rectopexy in 35 patients. Incontinence improved in 27% of patients, and constipation improved in 19% but worsened in 27%. The recurrence rate was 3% (1/35) after a mean follow-up of 36 months. A study on 46 patients with laparoscopic Orr-Loygue procedure with posterior mobilization found a significant reduction in incontinence score after 1 year, but there were no changes in the use of laxatives. The recurrence rate was 4% after a median follow-up of 1.5 years
| Study group | Role | What they receive |
|---|---|---|
| Laproscopic posterior mesh rectopexy (Wells or LPMR) | Experimental | After complete rectal mobilization, a mesh is inserted between the sacrum and the posterior rectum, sutured into the rectum, and fixed to the promontory. The mortality rates ranged from 0% to 1.2%, and recurrence rates ranged from 0% to 11% There was an overall improvement in continence (74%-100%), with conflicting results regarding constipation. New-onset constipation in 5% to 44% of patients was reported Receives: Procedure: Laproscopic posterior mesh rectopexy (Wells or LPMR) |
| Laparoscopic lateral mesh rectopexy (Orr-Loygue) | Experimental | This procedure involves complete mobilization of the rectum with two mesh strips sutured laterally to the rectal wall on both sides, and they were suspended to the promontory. There are several studies on this procedure using a laparoscopic approach. Lechaux et al. performed laparoscopic Orr-Loygue rectopexy in 35 patients. Incontinence improved in 27% of patients, and constipation improved in 19% but worsened in 27%. The recurrence rate was 3% (1/35) after a mean follow-up of 36 months. A study on 46 patients with laparoscopic Orr-Loygue procedure with posterior mobilization found a significant reduction in incontinence score after 1 year, but there were no changes in the use of laxatives. The recurrence rate was 4% after a median follow-up of 1.5 years. Receives: Procedure: Laparoscopic lateral mesh rectopexy (Orr-Loygue) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Operative time
Operative time will be measured (Time Frame: from inflation of abdomen till deflation in laparoscopic repair and from skin incision up to skin closure in open repair)
Measured: Until the conclusion of the surgical procedure
Intraoperative injuries
Intra operative injuries will be recorded including bowel or vascular injuries
Measured: Until the conclusion of the surgical procedure
Secondary outcomes (3)
Improving of symptoms
Laparoscopic lateral mesh rectopexy versus posterior mesh rectopexy regarding to improving of symptoms will be recorded
Measured: 28 days after surgery
Recurrence rate
Laparoscopic lateral mesh rectopexy versus posterior mesh rectopexy regarding to recurrence rate will be recorded The recurrence rate was 3% (1/35) after a mean follow-up of 36 months in laparoscopic lateral mesh rectopexy (Orr-Loygue) and recurrence rates ranged from 0% to 11% in laproscopic posterior mesh rectopexy (Wells or LPMR)
Measured: 28 days after surgery
Complications
Complications will be recorded such as early as bleeding, incontinence, intestinal obstruction, late as constipation, sexual dysfunction, intestinal obstruction, erosion of mesh
Measured: 28 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2024
- Study start15 Aug 2024
- Primary completion1 Oct 2026 (estimated)
- Study completion1 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Posterior LaparoscopicStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Omar Mohamed Ahmed Mohamed Makhlouf, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06559085
- Sponsor's protocol ID
- 04-2024-100197
- Status last verified
- Aug 2024
- First submitted
- 10 Aug 2024
- Last updated
- 19 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Posterior Versus Lateral Laparoscopic Mesh Rectopexy for the Management of Complete Rectal Prolapse
- ClinicalTrials.gov ID
- NCT06559085
- Acronym / sponsor ID
- 04-2024-100197
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 15 Aug 2024 (actual)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 1 Oct 2026 (estimated)
- First posted
- 19 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Aim of the study is to evaluate the outcomes of two different methods of mesh placement during laparoscopic rectopexy for the management of complete rectal prolapse lateral versus posterior mesh rectopexy
Detailed description
Rectal prolapse is the full-thickness prolapse of the rectum, in which the rectum passes externally beyond the anal sphincters. It is a somewhat rare condition, estimated to occur in less than 0.5% of the population. Rectal prolapse has a 9:1 female predominance, and while it is occasionally seen in younger individuals, the incidence increases with age.
Surgical approaches for rectal prolapse can be divided into perineal and abdominal approaches. Traditionally, a perineal procedure such as Delorme or Altemeir operation was commonly used in elderly or frail patients while an abdominal procedure such as rectopexy with or without resection was reserved for younger and fitter patients. The frequency of laparoscopic abdominal repair of rectal prolapse has increased in recent years, with mesh rectopexy being the most popular procedure.
The mesh rectopexy operation was first described by Ripstein10 in 1952. Again, after mobilization of the rectum, an anterior sling of synthetic material (either absorbable or non-absorbable) is placed in front of the rectum and sutured to the sacral promontory. The rationale for this is to restore the natural curve of the rectum, which reduces the effect of downward abdominal pressure. The use of a non-elastic synthetic graft provides a firm anterior fascial support even in patients with significant pelvic floor descent, returning the rectum to a normal anatomical position.
The act of mobilization, suture, and fibrosis keeps the rectum fixed in position as adhesions form, attaching the rectum to the presacral fascia. Although SR is considered a good option for the cure of rectal prolapse/IS in both men and women, some reviews of this procedure noted a better overall clinical outcome in men. This may be due to occult sphincter defects in women, and failure to detect these defects before surgery owing to the lack of routine endoanal ultrasonography in the earlier years of prolapse surgery
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laproscopic posterior mesh rectopexy (Wells or LPMR) | Experimental | Procedure: Laproscopic posterior mesh rectopexy (Wells or LPMR)After complete rectal mobilization, a mesh is inserted between the sacrum and the posterior rectum, sutured into the rectum, and fixed to the promontory. The mortality rates ranged from 0% to 1.2%, and recurrence rates ranged from 0% to 11% There was an overall improvement in continence (74%-100%), with conflicting results regarding constipation. New-onset constipation in 5% to 44% of patients was reported |
| Laparoscopic lateral mesh rectopexy (Orr-Loygue) | Experimental | Procedure: Laparoscopic lateral mesh rectopexy (Orr-Loygue)This procedure involves complete mobilization of the rectum with two mesh strips sutured laterally to the rectal wall on both sides, and they were suspended to the promontory. There are several studies on this procedure using a laparoscopic approach. Lechaux et al. performed laparoscopic Orr-Loygue rectopexy in 35 patients. Incontinence improved in 27% of patients, and constipation improved in 19% but worsened in 27%. The recurrence rate was 3% (1/35) after a mean follow-up of 36 months. A study on 46 patients with laparoscopic Orr-Loygue procedure with posterior mobilization found a significant reduction in incontinence score after 1 year, but there were no changes in the use of laxatives. The recurrence rate was 4% after a median follow-up of 1.5 years. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age from 18 to 70 years.
- Both sexes.
- Patients with complete rectal prolapse.
Key exclusion criteria (3 listed)
- Unfit for surgery
- Impaired coagulation profile
- Contraindication of laparoscopy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laproscopic posterior mesh rectopexy (Wells or LPMR)After complete rectal mobilization, a mesh is inserted between the sacrum and the posterior rectum, sutured into the rectum, and fixed to the promontory. The mortality rates ranged from 0% to 1.2%, and recurrence rates ranged from 0% to 11% There was an overall improvement in continence (74%-100%), with conflicting results regarding constipation. New-onset constipation in 5% to 44% of patients was reported | Procedure or surgery | Laproscopic posterior mesh rectopexy (Wells or LPMR) |
| Laparoscopic lateral mesh rectopexy (Orr-Loygue)This procedure involves complete mobilization of the rectum with two mesh strips sutured laterally to the rectal wall on both sides, and they were suspended to the promontory. There are several studies on this procedure using a laparoscopic approach. Lechaux et al. performed laparoscopic Orr-Loygue rectopexy in 35 patients. Incontinence improved in 27% of patients, and constipation improved in 19% but worsened in 27%. The recurrence rate was 3% (1/35) after a mean follow-up of 36 months. A study on 46 patients with laparoscopic Orr-Loygue procedure with posterior mobilization found a significant reduction in incontinence score after 1 year, but there were no changes in the use of laxatives. The recurrence rate was 4% after a median follow-up of 1.5 years | Procedure or surgery | Laparoscopic lateral mesh rectopexy (Orr-Loygue) |
Primary outcome
Operative time
Time frame: Until the conclusion of the surgical procedure
Operative time will be measured (Time Frame: from inflation of abdomen till deflation in laparoscopic repair and from skin incision up to skin closure in open repair)
Intraoperative injuries
Time frame: Until the conclusion of the surgical procedure
Intra operative injuries will be recorded including bowel or vascular injuries
3 secondary outcomes
Improving of symptoms
Time frame: 28 days after surgery
Recurrence rate
Time frame: 28 days after surgery
Complications
Time frame: 28 days after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2024.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Related trials for Posterior Laparoscopic
Recruiting
SPADE Clinical Trial.
Early Gastric Cancer, Adenocarcinoma of the Stomach
Not yet recruiting
PQLB vs TFPB in HALDN
Analgesia, Donor Nephrectomy
Recruiting
LAparoscopic Preventive PRErectal Mesh
Urogenital Prolapse
Recruiting
Ultrasound-Guided RSCTL vs EOIP Block for Analgesia in Sleeve Gastrectomy
Patient Satisfaction
Recruiting
Posterior Transversus Abdominis Plane Block Combined With Sacral Multifidus Plane Block Versus Posterior Transversus Abdominis Plane Block for Laparoscopic Colorectal Surgery
Anesthesia, Posterior Transversus Abdominis Plane Block
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laproscopic posterior mesh rectopexy (Wells or LPMR) and Laparoscopic lateral mesh rectopexy (Orr-Loygue) in people with Posterior Laparoscopic and Lateral Laparoscopic, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Omar M Makhlouf, Master (00201022533837, omarmakhlof1993@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Operative time (time frame: Until the conclusion of the surgical procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2024.