Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Clinical Phase
NA
Total Enrollment
70 participants
Study Classification
INTERVENTIONAL
Study Start Date
2017-01-01
Study Completion Date
2021-03-01
Brief Summary
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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
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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).
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
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Rectal Prolapse
Defecation Disorder
Rectocele; Female
Surgery
Keywords
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Obstructed defecation syndrome
Transanal rectal prolassectomy
Laparoscopic ventral mesh rectopexy
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
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.
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.
Primary Study Purpose
TREATMENT
Blinding Strategy
SINGLE
Outcome Assessors
Study Groups
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Group STARR
Patients undergoing transanal prolassectomy with mechanical stapler (STARR: Stapled Trans Anal Rectal Resection) randomly
Group Type
EXPERIMENTAL
STARR (Stapled Trans Anal Rectal Resection)
Intervention Type
PROCEDURE
Patients randomly assigned to surgical intervention of STARR (Stapled Trans Anal Rectal Resection)
Group LVR
Patients undergoing Laparoscopic suspensory correction of rectal prolapse by ventral rectopexy with biological prosthesis (LVR) randomly
Group Type
EXPERIMENTAL
LVR (Laparoscopic Ventral Rectopexy)
Intervention Type
PROCEDURE
Patients randomly assigned to surgical intervention of LVR (Laparoscopic Ventral Rectopexy)
Interventions
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STARR (Stapled Trans Anal Rectal Resection)
Patients randomly assigned to surgical intervention of STARR (Stapled Trans Anal Rectal Resection)
Intervention Type
PROCEDURE
LVR (Laparoscopic Ventral Rectopexy)
Patients randomly assigned to surgical intervention of LVR (Laparoscopic Ventral Rectopexy)
Intervention Type
PROCEDURE
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
Exclusion Criteria
* 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
* 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.
* 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
* 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.
Minimum Eligible Age
18 Years
Eligible Sex
FEMALE
Accepts Healthy Volunteers
No
Sponsors
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University Hospital of Ferrara
OTHER
Sponsor Role
lead
Responsible Party
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Simona Ascanelli
Principal Investigator
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Simona Ascanelli
Role: PRINCIPAL_INVESTIGATOR
Surgical Department University Hospital Ferrara Italy
Locations
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Surgery 2 Surgical Department, Sant'Anna University Hospital Ferrara, Italy
Ferrara, , Italy
Site Status
Countries
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Italy
References
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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.
Reference Type
BACKGROUND
Khaikin 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.
Reference Type
BACKGROUND
Rao SS. Dyssynergic defecation. Gastroenterol Clin North Am. 2001 Mar;30(1):97-114. doi: 10.1016/s0889-8553(05)70169-2.
Reference Type
BACKGROUND
Podzemny 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.
Reference Type
BACKGROUND
Gunner 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.
Reference Type
BACKGROUND
Senapati 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.
Reference Type
BACKGROUND
Emile 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.
Reference Type
BACKGROUND
van 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.
Reference Type
BACKGROUND
Altomare 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.
Reference Type
BACKGROUND
Marquis 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.
Reference Type
BACKGROUND
Clavien 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.
Reference Type
BACKGROUND
Cariou 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.
Reference Type
BACKGROUND
Kluivers 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.
Reference Type
BACKGROUND
Agachan 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.
Reference Type
BACKGROUND
Vaizey 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.
Reference Type
BACKGROUND
Barber MD, Walters MD, Bump RC. Short forms of two condition-specific quality-of-life questionnaires for women with pelvic floor disorders (PFDI-20 and PFIQ-7). Am J Obstet Gynecol. 2005 Jul;193(1):103-13. doi: 10.1016/j.ajog.2004.12.025.
Reference Type
BACKGROUND
Barber MD, Chen Z, Lukacz E, Markland A, Wai C, Brubaker L, Nygaard I, Weidner A, Janz NK, Spino C. Further validation of the short form versions of the Pelvic Floor Distress Inventory (PFDI) and Pelvic Floor Impact Questionnaire (PFIQ). Neurourol Urodyn. 2011 Apr;30(4):541-6. doi: 10.1002/nau.20934. Epub 2011 Feb 22.
Reference Type
BACKGROUND
Sileri P, Franceschilli L, de Luca E, Lazzaro S, Angelucci GP, Fiaschetti V, Pasecenic C, Gaspari AL. Laparoscopic ventral rectopexy for internal rectal prolapse using biological mesh: postoperative and short-term functional results. J Gastrointest Surg. 2012 Mar;16(3):622-8. doi: 10.1007/s11605-011-1793-2. Epub 2012 Jan 7.
Reference Type
BACKGROUND
Jayne DG, Schwandner O, Stuto A. Stapled transanal rectal resection for obstructed defecation syndrome: one-year results of the European STARR Registry. Dis Colon Rectum. 2009 Jul;52(7):1205-12; discussion 1212-4. doi: 10.1007/DCR.0b013e3181a9120f.
Reference Type
BACKGROUND
Study Documents
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Document Type: Study Protocol
View DocumentDocument Type: Statistical Analysis Plan
View DocumentDocument Type: Informed Consent Form
View DocumentOther Identifiers
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129/2021/Sper/AOUFe
Identifier Type: -
Identifier Source: org_study_id