Rectal ProlapseNCT04892108
Rectal Prolapse With ODS. STARR vs LVR.
A study testing STARR (Stapled Trans Anal Rectal Resection) and LVR (Laparoscopic Ventral Rectopexy) in people with Rectal Prolapse and Defecation Disorder, run by University Hospital of Ferrara at 1 site in Italy.
Trial summary
The objective of the study will be to evaluate the clinical and functional outcome of patients with obstructed defecation sndrome (ODS) associated to internal rectal prolapse, treated with transanal prolassectomy (STARR) surgery compared to those treated with laparoscopic ventral rectopexy (LVR). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Rectal Prolapse, Defecation Disorder, Rectocele; Female
- What is being tested?
- STARR (Stapled Trans Anal Rectal Resection) and LVR (Laparoscopic Ventral Rectopexy)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jan 2017to 1 Mar 2021
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- female gender,
- the presence of rectorectal or rectoanal intussusception as main cause of ODS, confirmed by defecography,
- type of operation performed (STARR or LVR),
- ODS score > 14 [17]
- PACQoL >32 [18]
- ODS symptoms for at least 12 months prior to enrollment
- Failure of at least 6 months of medical therapy
Who cannot join
- male gender,
- severe fecal incontinence (CCS score>6, Maximum Resting Pressure at rectal manometry < 50 mmHg),
- combined procedures
- previous surgery on rectum or anus for cancer or rectal prolapse, inflammatory bowel disease, other type of surgery to relieve ODS
- pregnancy,
- anismus or dissinergic defecation
Show all 12Show fewer
- full-thickness prolapse
- stress urinary incontinence associated
- histerocele or cystocele associated (since we usually correct both defects in the same surgical procedure)
- prior pelvic radiotherapy
- slow transit constipation defined as ≤ 2 bowel movements per week,
- any psychiatric diseases.
Trial locations and contacts
1 site in 1 country.
Italy1 site
Surgery 2 Surgical Department, Sant'Anna University Hospital Ferrara, Italy
Ferrara, 44124
About this study
Official title: Surgical Treatment of Internal Rectal Prolapse Associated With Obstructed Defecation: Transanal Prolassectomy Versus Laparoscopic Ventral Rectopexy. Randomized Controlled Trial.
The objective of the study will be to evaluate the clinical and functional outcome of patients with obstructed defecation sndrome (ODS) associated to internal rectal prolapse, treated with transanal prolassectomy (STARR) surgery compared to those treated with laparoscopic ventral rectopexy (LVR).
Read the detailed description
This randomized controlled trial (single center, prospective, randomized controlled, parallel, and single-blind trial) is designed to compare the outcome of patients with ODS and rectal prolapse undergoing transanal prolapsectomy with mechanical stapler (STARR) versus laparoscopic ventral rectopexy (LVR), with the aim of evaluating the most appropriate surgical choice.
The study will be conducted at the Surgical Unit 2 of the University Hospital of Ferrara, Italy. Patients suffering from rectal prolapse and ODS that will refer to the colorectal and pelvic floor clinic of the University Hospital Ferrara, and eligible for surgery, will be evaluated consecutively after expressing consent to participate in the study by signing an informed consent.
The duration of the study for each patient will be expected to be 48 months with follow-up at 1, 3, 6, 12, 24, 36, and 48 months postoperatively.
Eligible patients will receive information about participating in the trial by their surgeon. Consecutive eligible patients will be randomly assigned to one of two groups with a 1:1 equal allocation ratio.
Patients eligible for the study will be randomized on a 1:1 basis to undergo transanal prolassectomy (Group 1: STARR) or laparoscopic ventral rectopexy with mesh placement (Group 2: LVR).
An independent individual will perform randomization using a software randomization program. Randomization will be performed by a randomized list. The assignment sequence will be generated from a random numerical series generated through a computerized list. Randomization will be in blocks of 4. Group assignments will be unknown to those responsible for data collection and those who will be responsible for statistical analysis and clinical evaluation of patients.
The diagnosis of ODS will be attributed after clinical evaluation at the colorectal clinic and on the basis of the presence of one or more symptoms associated with this disorder, such as to reach a score of 14 and above according to the validated score of ODS of Altomare.
Assessment After recruitment and consent, all patients under study will be asked and collected demographic and clinical information with comorbidities (in particular diabetes, fibromyalgia, depressive disorders, neurological diseases, COPD), parity, previous pelvic surgery, type of surgery, time of hospitalization and any complications (according to Clavien-Dindo classification).
Data concerning the grade of rectoanal prolapse, according with Oxford Classification [20], and rectocele grading will be collected through outpatient proctological evaluation associated with proctoscopy, rectal manometry, and Rx defecography. Colonoscopy will be also performed in every patient to exclude colorectal cancer.
The severity of the ODS will be scored with the Altomare's ODS scoring system. Constipation and fecal incontinence will be measured by obtaining their scores through the administration of validated questionnaires such as the Wexner Constipation score, and the Cleveland Clinic Fecal Incontinence Score (CCFI).
Quality of life will be also evaluated by the patient assessment of constipation quality-of-life (PAC-Qol) questionnaire. The study of eventually associated pelvic distress will be assessed by administering validated questionnaires such as the Pelvic Floor Distress Inventory (PFDI-score, short form) and the Pelvic Floor Impact Questionnaire (PFQI-score, short form).
The scores obtained, as well as the presence of symptoms (fecal incontinence, constipation, or ODS) will be calculated before and after surgery (at 6, 12, 24, 36, and 48 months). All patients will be followed up on an outpatient basis at 7 days, 1 month, 3 months, 6 months, 12 ,24, 36, and 48 months after surgery. Rectal manometry and defecography will be performed after 12 months after surgery.
Surgical intervention All the procedures will be performed by a single surgeon (SA). The LVR technique used for this protocol is as previously described. Subjects randomized to this arm will receive a standard LVR. Briefly, the peritoneum is opened over the right side of the sacral promontory. The mesorectum is dissected and extended in an inverted J-form along the right side. The rectovaginal septum is opened to the pelvic floor. Biologic mesh (Permacol) is sutured to the ventral aspect of the rectum with non-readsorbable stitches. The proximal end of the mesh is fixed on the anterior longitudinal ligament at sacral promontory with nonabsorbable tacks. The incised peritoneum is then closed to over the mesh.
Subjects randomized to STARR arm will undergo a STARR procedure. Briefly, a circular anal dilator is introduced into the rectum. The purse-string anoscope is used to complete the anterior hemi-circumference purse-string suture, about 2-3 cm above the haemorrhoidal apex. A 33-mm circular stapler (Ethicon, ppH01) is opened, inserted until crossing the purse-string which is then tied with a knot. Then the stapler is closed and fired. The same hemi-circumference purse-string suture is performed in the posterior rectal wall. A second application of the stapler on the posterior wall is inserted, closed and fired.
The duration of the study will be 2 years. The study will be conducted in accordance with the principles of Helsinki Declaration, with approval of the medical ethics review board of S. Anna University Hospital. A written informed consent will be obtained from all enrolled patients.
The report will comply with the strengthening the reporting of randomized studies (CONSORT).
- Conditions
- Rectal Prolapse, Defecation Disorder, Rectocele; Female, Surgery
- Being tested
- STARR (Stapled Trans Anal Rectal Resection), LVR (Laparoscopic Ventral Rectopexy)
- Keywords
- Obstructed defecation syndrome, Transanal rectal prolassectomy, Laparoscopic ventral mesh rectopexy
- Medical subject headings
- Rectal Prolapse, Rectocele
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STARR (Stapled Trans Anal Rectal Resection)Procedure or surgery
Patients randomly assigned to surgical intervention of STARR (Stapled Trans Anal Rectal Resection)
LVR (Laparoscopic Ventral Rectopexy)Procedure or surgery
Patients randomly assigned to surgical intervention of LVR (Laparoscopic Ventral Rectopexy)
| Study group | Role | What they receive |
|---|---|---|
| Group STARR | Experimental | Patients undergoing transanal prolassectomy with mechanical stapler (STARR: Stapled Trans Anal Rectal Resection) randomly Receives: Procedure: STARR (Stapled Trans Anal Rectal Resection) |
| Group LVR | Experimental | Patients undergoing Laparoscopic suspensory correction of rectal prolapse by ventral rectopexy with biological prosthesis (LVR) randomly Receives: Procedure: LVR (Laparoscopic Ventral Rectopexy) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of different outcomes in relief from ODS after surgery in both groups
In order to evaluate the short- and long-term efficacy of STARR procedure compared to LVR, the percentage of changes in total ODS, PAC-QoL, PFDI, PFQI, Wexner Constipation, the Cleveland Clinic Fecal Incontinence (CCFI) scores between baseline and 6, 12, 24, 36, and 48 months after surgery, were adopted as primary outcome.
Measured: 4 years
Secondary outcomes (5)
short-term postoperative complications (within 30 days after surgery)
short-term postoperative complications (within 30 days after surgery) in the two groups (according to Clavien-Dindo classification)
Measured: 4 years
long-term postoperative complications
Mesh-related complications, rectal stenosis
Measured: 4 years
recurrence or persistence of rectal prolapse
to evaluate recurrence or persistence of rectal prolapse (diagnosed clinically and by postoperative defecography) in both groups, and the need for subsequent corrective surgery
Measured: 4 years
recurrence or persistence of ODS (Obstructed defecation syndrome)
recurrence or persistence of ODS if ODS score > 10
Measured: 4 years
patient satisfaction in terms of pain
patient satisfaction measured by a VAS (Visual Analogue Scale: evaluation of pain in mm: from 0 to 4 mm: no pain; from 5 to 44 mm: little pain; from 45 to 74 mm: moderate pain; from 75 to 100 mm: severe pain
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2021
- Study start1 Jan 2017
- Primary completion1 Jan 2019
- Study completion1 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for Rectal ProlapseStudies of the same condition, open and under way.
- 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
- Model description
- This randomized controlled trial is designed to compare the outcome of patients with obstructed defecation syndrome (ODS) and rectal prolapse undergoing transanal prolassectomy surgery with mechanical stapler (STARR: stapled transanal rectal resection) versus laparoscopic ventral rectopexy (LVR) surgery, with the aim of evaluating the most appropriate surgical choice. Patients eligible for the study will be randomized on a 1:1 basis to undergo transanal prolassectomy (Group 1: STARR) or laparoscopic ventral rectopexy with mesh placement (Group 2: LVR). Randomization will be performed by a randomized list. The assignment sequence will be generated from a random numerical series generated through a computerized list. Randomization will be in blocks of 4. Group assignments will be unknown to those responsible for data collection and those who will be responsible for statistical analysis and clinical evaluation of patients.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital of Ferrara
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Simona Ascanelli, University Hospital of Ferrara
- Investigators
- Simona Ascanelli, Principal investigator, Surgical Department University Hospital Ferrara Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04892108
- Sponsor's protocol ID
- 129/2021/Sper/AOUFe
- Status last verified
- May 2021
- First submitted
- 11 Apr 2021
- Last updated
- 28 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hicks CW, Weinstein M, Wakamatsu M, Savitt L, Pulliam S, Bordeianou L. In patients with rectoceles and obstructed defecation syndrome, surgery should be the option of last resort. Surgery. 2014 Apr;155(4):659-67. doi: 10.1016/j.surg.2013.11.013. Epub 2013 Dec 5.
PubMed 24508117Khaikin M, Wexner SD. Treatment strategies in obstructed defecation and fecal incontinence. World J Gastroenterol. 2006 May 28;12(20):3168-73. doi: 10.3748/wjg.v12.i20.3168.
PubMed 16718835Rao SS. Dyssynergic defecation. Gastroenterol Clin North Am. 2001 Mar;30(1):97-114. doi: 10.1016/s0889-8553(05)70169-2.
PubMed 11394039Podzemny V, Pescatori LC, Pescatori M. Management of obstructed defecation. World J Gastroenterol. 2015 Jan 28;21(4):1053-60. doi: 10.3748/wjg.v21.i4.1053.
PubMed 25632177Gunner CK, Senapati A, Northover JM, Brown SR. Life after PROSPER. What do people do for external rectal prolapse? Colorectal Dis. 2016 Aug;18(8):811-4. doi: 10.1111/codi.13255.
PubMed 27481719Senapati A, Gray RG, Middleton LJ, Harding J, Hills RK, Armitage NC, Buckley L, Northover JM; PROSPER Collaborative Group. PROSPER: a randomised comparison of surgical treatments for rectal prolapse. Colorectal Dis. 2013 Jul;15(7):858-68. doi: 10.1111/codi.12177.
PubMed 23461778Emile SH, Elfeki H, Shalaby M, Sakr A, Sileri P, Wexner SD. Perineal resectional procedures for the treatment of complete rectal prolapse: A systematic review of the literature. Int J Surg. 2017 Oct;46:146-154. doi: 10.1016/j.ijsu.2017.09.005. Epub 2017 Sep 7.
PubMed 28890414van den Esschert JW, van Geloven AA, Vermulst N, Groenedijk AG, de Wit LT, Gerhards MF. Laparoscopic ventral rectopexy for obstructed defecation syndrome. Surg Endosc. 2008 Dec;22(12):2728-32. doi: 10.1007/s00464-008-9771-9. Epub 2008 Mar 5.
PubMed 18320283Altomare DF, Spazzafumo L, Rinaldi M, Dodi G, Ghiselli R, Piloni V. Set-up and statistical validation of a new scoring system for obstructed defaecation syndrome. Colorectal Dis. 2008 Jan;10(1):84-8. doi: 10.1111/j.1463-1318.2007.01262.x. Epub 2007 Apr 18.
PubMed 17441968Marquis P, De La Loge C, Dubois D, McDermott A, Chassany O. Development and validation of the Patient Assessment of Constipation Quality of Life questionnaire. Scand J Gastroenterol. 2005 May;40(5):540-51. doi: 10.1080/00365520510012208.
PubMed 16036506Clavien PA, Barkun J, de Oliveira ML, Vauthey JN, Dindo D, Schulick RD, de Santibanes E, Pekolj J, Slankamenac K, Bassi C, Graf R, Vonlanthen R, Padbury R, Cameron JL, Makuuchi M. The Clavien-Dindo classification of surgical complications: five-year experience. Ann Surg. 2009 Aug;250(2):187-96. doi: 10.1097/SLA.0b013e3181b13ca2.
PubMed 19638912Cariou de Vergie L, Venara A, Duchalais E, Frampas E, Lehur PA. Internal rectal prolapse: Definition, assessment and management in 2016. J Visc Surg. 2017 Feb;154(1):21-28. doi: 10.1016/j.jviscsurg.2016.10.004. Epub 2016 Nov 16.
PubMed 27865742Kluivers KB, Hendriks JC, Shek C, Dietz HP. Pelvic organ prolapse symptoms in relation to POPQ, ordinal stages and ultrasound prolapse assessment. Int Urogynecol J Pelvic Floor Dysfunct. 2008 Sep;19(9):1299-302. doi: 10.1007/s00192-008-0634-7. Epub 2008 May 9.
PubMed 18465076Agachan F, Chen T, Pfeifer J, Reissman P, Wexner SD. A constipation scoring system to simplify evaluation and management of constipated patients. Dis Colon Rectum. 1996 Jun;39(6):681-5. doi: 10.1007/BF02056950.
PubMed 8646957Vaizey CJ, Carapeti E, Cahill JA, Kamm MA. Prospective comparison of faecal incontinence grading systems. Gut. 1999 Jan;44(1):77-80. doi: 10.1136/gut.44.1.77.
PubMed 9862829
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgical Treatment of Internal Rectal Prolapse Associated With Obstructed Defecation: Transanal Prolassectomy Versus Laparoscopic Ventral Rectopexy. Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT04892108
- Acronym / sponsor ID
- 129/2021/Sper/AOUFe
- Conditions
- Rectal Prolapse, Defecation Disorder, Rectocele; Female, Surgery
- Keywords
- Obstructed defecation syndrome, Transanal rectal prolassectomy, Laparoscopic ventral mesh rectopexy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- University Hospital of FerraraUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 1 Jan 2019 (actual)
- Study completion
- 1 Mar 2021 (actual)
- First posted
- 19 May 2021 (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.
The objective of the study will be to evaluate the clinical and functional outcome of patients with obstructed defecation sndrome (ODS) associated to internal rectal prolapse, treated with transanal prolassectomy (STARR) surgery compared to those treated with laparoscopic ventral rectopexy (LVR).
Detailed description
This randomized controlled trial (single center, prospective, randomized controlled, parallel, and single-blind trial) is designed to compare the outcome of patients with ODS and rectal prolapse undergoing transanal prolapsectomy with mechanical stapler (STARR) versus laparoscopic ventral rectopexy (LVR), with the aim of evaluating the most appropriate surgical choice.
The study will be conducted at the Surgical Unit 2 of the University Hospital of Ferrara, Italy. Patients suffering from rectal prolapse and ODS that will refer to the colorectal and pelvic floor clinic of the University Hospital Ferrara, and eligible for surgery, will be evaluated consecutively after expressing consent to participate in the study by signing an informed consent.
The duration of the study for each patient will be expected to be 48 months with follow-up at 1, 3, 6, 12, 24, 36, and 48 months postoperatively.
Eligible patients will receive information about participating in the trial by their surgeon. Consecutive eligible patients will be randomly assigned to one of two groups with a 1:1 equal allocation ratio.
Patients eligible for the study will be randomized on a 1:1 basis to undergo transanal prolassectomy (Group 1: STARR) or laparoscopic ventral rectopexy with mesh placement (Group 2: LVR).
An independent individual will perform randomization using a software randomization program. Randomization will be performed by a randomized list. The assignment sequence will be generated from a random numerical series generated through a computerized list. Randomization will be in blocks of 4. Group assignments will be unknown to those responsible for data collection and those who will be responsible for statistical analysis and clinical evaluation of patients.
The diagnosis of ODS will be attributed after clinical evaluation at the colorectal clinic and on the basis of the presence of one or more symptoms associated with this disorder, such as to reach a score of 14 and above according to the validated score of ODS of Altomare.
Assessment After recruitment and consent, all patients under study will be asked and collected demographic and clinical information with comorbidities (in particular diabetes, fibromyalgia, depressive disorders, neurological diseases, COPD), parity, previous pelvic surgery, type of surgery, time of hospitalization and any complications (according to Clavien-Dindo classification).
Data concerning the grade of rectoanal prolapse, according with Oxford Classification [20], and rectocele grading will be collected through outpatient proctological evaluation associated with proctoscopy, rectal manometry, and Rx defecography. Colonoscopy will be also performed in every patient to exclude colorectal cancer.
The severity of the ODS will be scored with the Altomare's ODS scoring system. Constipation and fecal incontinence will be measured by obtaining their scores through the administration of validated questionnaires such as the Wexner Constipation score, and the Cleveland Clinic Fecal Incontinence Score (CCFI).
Quality of life will be also evaluated by the patient assessment of constipation quality-of-life (PAC-Qol) questionnaire. The study of eventually associated pelvic distress will be assessed by administering validated questionnaires such as the Pelvic Floor Distress Inventory (PFDI-score, short form) and the Pelvic Floor Impact Questionnaire (PFQI-score, short form).
The scores obtained, as well as the presence of symptoms (fecal incontinence, constipation, or ODS) will be calculated before and after surgery (at 6, 12, 24, 36, and 48 months). All patients will be followed up on an outpatient basis at 7 days, 1 month, 3 months, 6 months, 12 ,24, 36, and 48 months after surgery. Rectal manometry and defecography will be performed after 12 months after surgery.
Surgical intervention All the procedures will be performed by a single surgeon (SA). The LVR technique used for this protocol is as previously described. Subjects randomized to this arm will receive a standard LVR. Briefly, the peritoneum is opened over the right side of the sacral promontory. The mesorectum is dissected and extended in an inverted J-form along the right side. The rectovaginal septum is opened to the pelvic floor. Biologic mesh (Permacol) is sutured to the ventral aspect of the rectum with non-readsorbable stitches. The proximal end of the mesh is fixed on the anterior longitudinal ligament at sacral promontory with nonabsorbable tacks. The incised peritoneum is then closed to over the mesh.
Subjects randomized to STARR arm will undergo a STARR procedure. Briefly, a circular anal dilator is introduced into the rectum. The purse-string anoscope is used to complete the anterior hemi-circumference purse-string suture, about 2-3 cm above the haemorrhoidal apex. A 33-mm circular stapler (Ethicon, ppH01) is opened, inserted until crossing the purse-string which is then tied with a knot. Then the stapler is closed and fired. The same hemi-circumference purse-string suture is performed in the posterior rectal wall. A second application of the stapler on the posterior wall is inserted, closed and fired.
The duration of the study will be 2 years. The study will be conducted in accordance with the principles of Helsinki Declaration, with approval of the medical ethics review board of S. Anna University Hospital. A written informed consent will be obtained from all enrolled patients.
The report will comply with the strengthening the reporting of randomized studies (CONSORT).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This randomized controlled trial is designed to compare the outcome of patients with obstructed defecation syndrome (ODS) and rectal prolapse undergoing transanal prolassectomy surgery with mechanical stapler (STARR: stapled transanal rectal resection) versus laparoscopic ventral rectopexy (LVR) surgery, with the aim of evaluating the most appropriate surgical choice. Patients eligible for the study will be randomized on a 1:1 basis to undergo transanal prolassectomy (Group 1: STARR) or laparoscopic ventral rectopexy with mesh placement (Group 2: LVR). Randomization will be performed by a randomized list. The assignment sequence will be generated from a random numerical series generated through a computerized list. Randomization will be in blocks of 4. Group assignments will be unknown to those responsible for data collection and those who will be responsible for statistical analysis and clinical evaluation of patients.
| Arm | Type | Receives |
|---|---|---|
| Group STARR | Experimental | Procedure: STARR (Stapled Trans Anal Rectal Resection)Patients undergoing transanal prolassectomy with mechanical stapler (STARR: Stapled Trans Anal Rectal Resection) randomly |
| Group LVR | Experimental | Procedure: LVR (Laparoscopic Ventral Rectopexy)Patients undergoing Laparoscopic suspensory correction of rectal prolapse by ventral rectopexy with biological prosthesis (LVR) randomly |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- female gender,
- the presence of rectorectal or rectoanal intussusception as main cause of ODS, confirmed by defecography,
- type of operation performed (STARR or LVR),
- ODS score > 14 [17]
- PACQoL >32 [18]
Key exclusion criteria (12 listed)
- male gender,
- severe fecal incontinence (CCS score>6, Maximum Resting Pressure at rectal manometry < 50 mmHg),
- combined procedures
- previous surgery on rectum or anus for cancer or rectal prolapse, inflammatory bowel disease, other type of surgery to relieve ODS
- pregnancy,
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 |
|---|---|---|
| STARR (Stapled Trans Anal Rectal Resection)Patients randomly assigned to surgical intervention of STARR (Stapled Trans Anal Rectal Resection) | Procedure or surgery | Group STARR |
| LVR (Laparoscopic Ventral Rectopexy)Patients randomly assigned to surgical intervention of LVR (Laparoscopic Ventral Rectopexy) | Procedure or surgery | Group LVR |
Primary outcome
Evaluation of different outcomes in relief from ODS after surgery in both groups
Time frame: 4 years
In order to evaluate the short- and long-term efficacy of STARR procedure compared to LVR, the percentage of changes in total ODS, PAC-QoL, PFDI, PFQI, Wexner Constipation, the Cleveland Clinic Fecal Incontinence (CCFI) scores between baseline and 6, 12, 24, 36, and 48 months after surgery, were adopted as primary outcome.
5 secondary outcomes
short-term postoperative complications (within 30 days after surgery)
Time frame: 4 years
long-term postoperative complications
Time frame: 4 years
recurrence or persistence of rectal prolapse
Time frame: 4 years
recurrence or persistence of ODS (Obstructed defecation syndrome)
Time frame: 4 years
patient satisfaction in terms of pain
Time frame: 4 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2021.
- Background: PubMed 24508117Hicks CW, Weinstein M, Wakamatsu M, Savitt L, Pulliam S, Bordeianou L. In patients with rectoceles and obstructed defecation syndrome, surgery should be the option of last resort. Surgery. 2014 Apr;155(4):659-67. doi: 10.1016/j.surg.2013.11.013. Epub 2013 Dec 5.
- Background: PubMed 16718835Khaikin M, Wexner SD. Treatment strategies in obstructed defecation and fecal incontinence. World J Gastroenterol. 2006 May 28;12(20):3168-73. doi: 10.3748/wjg.v12.i20.3168.
- Background: PubMed 11394039Rao SS. Dyssynergic defecation. Gastroenterol Clin North Am. 2001 Mar;30(1):97-114. doi: 10.1016/s0889-8553(05)70169-2.
- Background: PubMed 25632177Podzemny V, Pescatori LC, Pescatori M. Management of obstructed defecation. World J Gastroenterol. 2015 Jan 28;21(4):1053-60. doi: 10.3748/wjg.v21.i4.1053.
- Background: PubMed 27481719Gunner CK, Senapati A, Northover JM, Brown SR. Life after PROSPER. What do people do for external rectal prolapse? Colorectal Dis. 2016 Aug;18(8):811-4. doi: 10.1111/codi.13255.
- Background: PubMed 23461778Senapati A, Gray RG, Middleton LJ, Harding J, Hills RK, Armitage NC, Buckley L, Northover JM; PROSPER Collaborative Group. PROSPER: a randomised comparison of surgical treatments for rectal prolapse. Colorectal Dis. 2013 Jul;15(7):858-68. doi: 10.1111/codi.12177.
- Background: PubMed 28890414Emile SH, Elfeki H, Shalaby M, Sakr A, Sileri P, Wexner SD. Perineal resectional procedures for the treatment of complete rectal prolapse: A systematic review of the literature. Int J Surg. 2017 Oct;46:146-154. doi: 10.1016/j.ijsu.2017.09.005. Epub 2017 Sep 7.
- Background: PubMed 18320283van den Esschert JW, van Geloven AA, Vermulst N, Groenedijk AG, de Wit LT, Gerhards MF. Laparoscopic ventral rectopexy for obstructed defecation syndrome. Surg Endosc. 2008 Dec;22(12):2728-32. doi: 10.1007/s00464-008-9771-9. Epub 2008 Mar 5.
- Background: PubMed 17441968Altomare DF, Spazzafumo L, Rinaldi M, Dodi G, Ghiselli R, Piloni V. Set-up and statistical validation of a new scoring system for obstructed defaecation syndrome. Colorectal Dis. 2008 Jan;10(1):84-8. doi: 10.1111/j.1463-1318.2007.01262.x. Epub 2007 Apr 18.
- Background: PubMed 16036506Marquis P, De La Loge C, Dubois D, McDermott A, Chassany O. Development and validation of the Patient Assessment of Constipation Quality of Life questionnaire. Scand J Gastroenterol. 2005 May;40(5):540-51. doi: 10.1080/00365520510012208.
- Background: PubMed 19638912Clavien PA, Barkun J, de Oliveira ML, Vauthey JN, Dindo D, Schulick RD, de Santibanes E, Pekolj J, Slankamenac K, Bassi C, Graf R, Vonlanthen R, Padbury R, Cameron JL, Makuuchi M. The Clavien-Dindo classification of surgical complications: five-year experience. Ann Surg. 2009 Aug;250(2):187-96. doi: 10.1097/SLA.0b013e3181b13ca2.
- Background: PubMed 27865742Cariou de Vergie L, Venara A, Duchalais E, Frampas E, Lehur PA. Internal rectal prolapse: Definition, assessment and management in 2016. J Visc Surg. 2017 Feb;154(1):21-28. doi: 10.1016/j.jviscsurg.2016.10.004. Epub 2016 Nov 16.
- Individual participant dataSharing planned: No
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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.
Simona Ascanelli principal investigator
Surgical Department University Hospital Ferrara Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing STARR (Stapled Trans Anal Rectal Resection) and LVR (Laparoscopic Ventral Rectopexy) in people with Rectal Prolapse and Defecation Disorder, run by University Hospital of Ferrara at 1 site in Italy.
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 7 inclusion and 12 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: finished, as of the sponsor's last update on 28 May 2021. 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 Italy. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of different outcomes in relief from ODS after surgery in both groups (time frame: 4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04892108, which also lists 19 linked publications.
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 28 May 2021.