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The Impact of NOSE-colectomy on Fertility and Quality of Life Among Patients With Colorectal Endometriosis (NOSERES)

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ClinicalTrials.gov Identifier: NCT04109378
Recruitment Status : Recruiting
First Posted : September 30, 2019
Last Update Posted : September 30, 2019
Sponsor:
Information provided by (Responsible Party):
Semmelweis University

Brief Summary:

Deep infiltrating endometriosis (DIE) represents the most severe form of endometriosis and is present in 20-35% of all women suffering from the disease. Intestinal nodules are observed in 3% to 37% of endometriosis patients. In cases of colorectal DIE, adequate therapy depends on the depth of infiltration and the size of the lesion as well as the woman's quality of life . Removal of the specimen after segmental bowel resection can be performed by either mini-laparotomy or by the natural orifice specimen extraction (NOSE) technique .

The assessment of the quality of life and fertility outcome of the patients was done by using electronic questionnaires before and after surgery.


Condition or disease Intervention/treatment Phase
Endometriosis Quality of Life Procedure: Surgical procedures( conventional laparoscopic and NOSE technique) for the treatment of colorectal DIE Not Applicable

Detailed Description:

The conventional method raises concerns because this could disrupt the integrity of the abdominal wall. Moreover, extraction site laparotomy is associated with higher postoperative pain scores . The occurrence of particular complications such as incisional hernias and wound infections is also higher than after conventional laparoscopic procedures .

In order to avoid these complications, NOSE technique has been introduced. During NOSE colectomy the specimen is extracted through a natural orifice and an intracorporeal anastomosis is performed For the operative treatment of bowel endometriosis both transrectal and transvaginal NOSE have been performed.

From 1st of February 2018, 234 consecutive patients underwent segmental bowel resection because of colorectal DIE at the Dept. of Obstetrics and Gynecology Semmelweis University Budapest.

The surgical plan was made individually, tailored to the symptoms of the patients. Nodules larger than 3cm causing obstructive problems and affecting more than 50% of the bowel circumference or multifocal DIE nodules (less than 2 cm from the principal lesion) or multicentric (more than 2 cm from the principal lesion) nodules were treated by segmental resection and anastomosis.

Apart from obstructive sequelae severe (visual analog scale, VAS) endometriosis related pain represented surgical indication as well.

The procedures, namely the transrectal NOSE technique and the conventional segmental laparoscopic resection were randomized using simple randomization, the coin flipping method.

At the time of admission patients filled a questionnaire (Endometriosis Health Profile, EHP 30;Gastrointestinal Quality of Life Index,GIQLI; LARS-Low Anterior Resection Syndrome , and a validated questionnaire pain catastrophisation) regarding their symptoms and fertility .

The endometriosis related pain was measured by using Visual Analog Scale (VAS scores) The patients were asked to fill the questionnaires at 30 days, 60months, 1year and 2 years after the surgery.

During the present study investigators are planning an average follow-up of 24 months.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Simple randomization using the coin flipping method in order to compare the effect of two surgical methods on the quality of life and fertility among women operated for colorectal endometriosis.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Impact of NOSE-colectomy on Fertility and Quality of Life Among Patients With Colorectal Endometriosis
Actual Study Start Date : February 1, 2018
Estimated Primary Completion Date : February 1, 2021
Estimated Study Completion Date : February 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endometriosis

Arm Intervention/treatment
Active Comparator: Patients operated with conventional laparoscopic technique
Patients operated with conventional laparoscopic technique for colorectal DIE
Procedure: Surgical procedures( conventional laparoscopic and NOSE technique) for the treatment of colorectal DIE
Removal of the specimen after segmental bowel resection can be performed by either mini-laparotomy or by the natural orifice specimen extraction (NOSE) technique . The conventional method raises concerns because this could disrupt the integrity of the abdominal wall.

Active Comparator: Patients operated with NOSE laparoscopic technique
Patients operated with NOSE technique for colorectal DIE
Procedure: Surgical procedures( conventional laparoscopic and NOSE technique) for the treatment of colorectal DIE
Removal of the specimen after segmental bowel resection can be performed by either mini-laparotomy or by the natural orifice specimen extraction (NOSE) technique . The conventional method raises concerns because this could disrupt the integrity of the abdominal wall.




Primary Outcome Measures :
  1. Quality of life after colorectal resection for DIE [ Time Frame: 240 months ]
    Impact of surgical technique on the quality of life. The outcome will be assessed using validated electronic questionnaires containing questions from Endometriosis Health Profile. This is a core questionnaire which consists of five scales (pain, control and powerlessness, emotional well-being, social support, and self-image) contains a total of 30 items.

  2. LARS score before and after colorectal resection for DIE [ Time Frame: 240 months ]
    The Low Anterior Resection Syndrome (LARS) is a common complication that occures after colorectal surgery. The LARS score is a simple self-administered questionnaire measuring bowel dysfunction after rectal surgery. Contains questions regarding incontinence, emptying difficulties, urgency, and frequency. The calculated score ranges from 0 to 42, with a score of 0-20 representing no LARS, a score of 21-29 representing minor LARS and a score of 30-42 representing major LARS.

  3. Endometriosis related pain before and after colorectal resection for DIE [ Time Frame: 240 months ]
    For the assessment of pre and postoperative pain a Visual Analogue Scale is used (from 1-10, where 1 is the lowest and 10 is the maximum score) to assess the pre- and postoperative quality of life.

  4. Infertility outcomes after colorectal resection for bowel endometriosis [ Time Frame: 240 months ]
    Number of pregnancies, cumulative pregnancy rate and take home baby rate after laparoscopic bowel resection


Secondary Outcome Measures :
  1. Complication rates after conventional and NOSE-colectomy performed for colorectal endometriosis [ Time Frame: 240 months ]

    The complication rates between the NOSE vs conventional specimen extraction technique will be examined. The difference between the complication rates will be presented according to Clavien-Dindo Classification System.

    As follows:

    Grade I Any deviation from the normal postoperative course without treatment by invasive interventions Grade II Requiring pharmacological treatment with drugs other than such allowed for grade I complications.

    Grade III

    Requiring surgical, endoscopic or radiological intervention

    • IIIa

    Intervention not under general anesthesia

    • IIIb

    Intervention under general anesthesia Grade IV

    Life-threatening complication requiring IC/ICU-management

    • IVa

    single organ dysfunction (including dialysis)

    • IVb

    multiorgan dysfunction Grade V Death of a patient


  2. Hospital stay after colorectal resection perfomed for the treatment of bowel endometriosis [ Time Frame: 240 months ]
    The lenght of recovery after bowel resection will be assessed by the comparison of the hospital stay (mean +/- SD days)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Women of reproductive age suffering of DIE
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Women of reproductive age,
  • Patients with colorectal DIE and operated either using conventional or NOSE- colectomy technique

Exclusion Criteria:

  • Pregnancy
  • Patients without bowel resection

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04109378


Contacts
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Contact: Attila Bokor, MD, PhD +36703118868 attila.z.bokor@gmail.com
Contact: Reka Brubel, MD, PhD +3614591500 brubelreka@gmail.com

Locations
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Hungary
Semmelweis University Recruiting
Budapest, Hungary, 1088
Contact: Attila Bokor, MD, PhD    +36703118868    attila.z.bokor@gmail.com   
Contact: Reka Brubel    +3604591500    brubelreka@gmail.com   
Sponsors and Collaborators
Semmelweis University
Investigators
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Study Director: Attila Bokor, MD, PhD Semmelweis University

Publications of Results:
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Responsible Party: Semmelweis University
ClinicalTrials.gov Identifier: NCT04109378    
Other Study ID Numbers: SemmlweisU
First Posted: September 30, 2019    Key Record Dates
Last Update Posted: September 30, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Semmelweis University:
Fertility
Colorectal endometriosis
Surgery
Additional relevant MeSH terms:
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Endometriosis
Genital Diseases, Female