Robotic assisted versus laparoscopic ventral rectopexy in the treatment of rectal prolapse or enterocele with secondary rectal intussusception

Robotic assisted versus laparoscopic ventral rectopexy in the treatment of rectal prolapse or enterocele with secondary rectal intussusseption: a randomised trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN88884232

Enrollment

Registered

2012-10-23

Start date

2012-02-01

Completion date

Unknown

Last updated

2020-01-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rectal prolapse or enterocele with secondary intussusseption Digestive System Rectal prolapse

Interventions

Robotic assisted versus laparoscopic ventral rectopexy

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1. Female patient between 18 and 85 years of age 2. Patient suitable for day-case surgery and general anaesthesia [American Society of Anesthesiologists (ASA 1-3)] 3. Previously untreated and uncomplicated rectal prolapse or enterocele 4. Isolated rectal prolapse or enterocele with intussusception

Exclusion criteria

Exclusion criteria: 1. Significant systemic illness (ASA > 4) 2. Suspicion of frozen pelvis 3. Pregnant or future plans for pregnancy

Design outcomes

Primary

Measure	Time frame
Current primary outcome measure as of 03/10/2019: 1. Defining the presence or absence of rectal prolapse and intussusseption with/without enterocele by MR-defecography 2. Three compartment anatomy evaluation by dynamic MRI using HMO classification for measurements Previous primary outcome measure: Anatomic result: 1. Clinical examination: defining the presence or absence of rectal prolapse/intussusseption 2. 3D endoanal ultrasound: situation of the mesh with regard to anal sphincter complex 3. MRI-defecography: objective measure of presence/absence of rectal prolapse/ intussusseption Functional result: 1. Symptom questionnaires: 1.1. Obstructive Defecation Score (ODS) 1.2. Wexner (for anal incontinence symptoms) 1.3. Pelvic Floor Disorder Interventory (PFDI-20), including Urinary Distress Inventory 6 (UDI-6) 1.4. Pelvic Organ Prolapse Distress Inventory 6 (POPDI-6) and Colorectal-Anal Distress Inventory 8 (CRADI-8) Quality of life impact: 1. A condition specific quality of life questionnaire: Pelvic Floor Impact Questionnaire - short form 7 (PFIQ-7) 2. 15D - A generic quality of life questionnaire	—

Measure

Time frame

Current primary outcome measure as of 03/10/2019: 1. Defining the presence or absence of rectal prolapse and intussusseption with/without enterocele by MR-defecography 2. Three compartment anatomy evaluation by dynamic MRI using HMO classification for measurements Previous primary outcome measure: Anatomic result: 1. Clinical examination: defining the presence or absence of rectal prolapse/intussusseption 2. 3D endoanal ultrasound: situation of the mesh with regard to anal sphincter complex 3. MRI-defecography: objective measure of presence/absence of rectal prolapse/ intussusseption Functional result: 1. Symptom questionnaires: 1.1. Obstructive Defecation Score (ODS) 1.2. Wexner (for anal incontinence symptoms) 1.3. Pelvic Floor Disorder Interventory (PFDI-20), including Urinary Distress Inventory 6 (UDI-6) 1.4. Pelvic Organ Prolapse Distress Inventory 6 (POPDI-6) and Colorectal-Anal Distress Inventory 8 (CRADI-8) Quality of life impact: 1. A condition specific quality of life questionnaire: Pelvic Floor Impact Questionnaire - short form 7 (PFIQ-7) 2. 15D - A generic quality of life questionnaire

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Secondary

Measure	Time frame
Current secondary outcome measures as of 03/10/2019: 1. Functional result by symptom questionnaires: 1.1. Obstructive Defecation Score (for obstructed defecation symptoms) 1.2. Wexner score (for anal incontinence symptoms) 1.3. Pelvic Floor Disorder Interventory (PFDI-20), including Urinary Distress Inventory 6 (UDI- 6), Pelvic Organ Prolapse Distress Inventory 6 (POPDI-6) and Colorectal-Anal Distress Inventory 8 (CRADI-8) 1.4 Sexual function: Pelvic Organ Prolapse / Urinary Incontinence Sexual Function Questionnaire (PISQ-12) 2. The effect on rectopexy to three compartment pelvic anatomy 2.1. Pelvic organ prolapse staging using pelvic organ prolapse quantification (POP-Q) method Previous secondary outcome measures: 1. Operative parameters and postoperative recovery 2. Cost-benefit analysis (HRQoL by using the 15D instrument) 3. The effect on rectopexy to gynacologic organs/prolapses: 3.1. Gynaecological examination and pelvic organ prolapse staging using pelvic organ prolapse quantification (POP-Q) method 3.2. Dynamic MRI using HMO classification for measurements 4. Sexual function: Pelvic Organ Prolapse / Urinary Incontinence Sexual Function Questionnaire (PISQ-12)	—

Measure

Time frame

Current secondary outcome measures as of 03/10/2019: 1. Functional result by symptom questionnaires: 1.1. Obstructive Defecation Score (for obstructed defecation symptoms) 1.2. Wexner score (for anal incontinence symptoms) 1.3. Pelvic Floor Disorder Interventory (PFDI-20), including Urinary Distress Inventory 6 (UDI- 6), Pelvic Organ Prolapse Distress Inventory 6 (POPDI-6) and Colorectal-Anal Distress Inventory 8 (CRADI-8) 1.4 Sexual function: Pelvic Organ Prolapse / Urinary Incontinence Sexual Function Questionnaire (PISQ-12) 2. The effect on rectopexy to three compartment pelvic anatomy 2.1. Pelvic organ prolapse staging using pelvic organ prolapse quantification (POP-Q) method Previous secondary outcome measures: 1. Operative parameters and postoperative recovery 2. Cost-benefit analysis (HRQoL by using the 15D instrument) 3. The effect on rectopexy to gynacologic organs/prolapses: 3.1. Gynaecological examination and pelvic organ prolapse staging using pelvic organ prolapse quantification (POP-Q) method 3.2. Dynamic MRI using HMO classification for measurements 4. Sexual function: Pelvic Organ Prolapse / Urinary Incontinence Sexual Function Questionnaire (PISQ-12)

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Countries

Finland

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026