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EndometriosisENDO-RESECTNCT03824054

Quality of Life in Patients Undergoing Colorectal Resection for Deep Infiltrating Endometriosis

An observational study of Endometriosis, run by Catholic University of the Sacred Heart at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The aim of this study is to evaluate the quality of life of patients undergoing colorectal resection for deep infiltrating endometriosis of the bowel. Questionnaires about pre operative status have been submitted retrospectively, while post operative questionnaires have been submitted prospectively during last follow… Read more about this study

Who is it for?
Ages 18 to 45 years, women only
Conditions the study is for
Endometriosis
What is being tested?
colorectal resection
Type of treatment
Surgery or procedure
How many people
50 participants
Where
1 siteItaly
Study dates
1 Oct 2005to 30 Nov 2018
Phase
Observational
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 45 years
  • Women only
  • No healthy volunteers
  • Adult

Study population: Patients affected by symptomatic deep infiltrating endometriosis involving the bowel and candidate to colo-rectal resection

Who may be able to join

  • Women aged between 18 and 45 years
  • Clinical diagnosis of deep endometriosis infiltrating the bowel
  • Women undergoing surgical removal with colorectal resection with or without loop ileostomy creation

Who cannot join

  • History of previous or ongoing neoplastic pathology
  • Contraindications to surgical intervention
  • Not complete eradicating surgery
  • Psychiatric disorders
  • Surgical, spontaneous or pharmacological menopause - Intestinal surgery different from segmental bowel resection and colorectal anastomosis

Trial locations and contacts

1 site in 1 country.

Italy1 site
  • Catholic University of Sacred Heart

    Rome, 00168

Other trials in Italy

About this study

Official title: Evaluation of Quality of Life and Gastrointestinal Well-being in Patients Undergoing Colorectal Resection for Deep Infiltrating Endometriosis. Retrospective Observational Cohort Study

The aim of this study is to evaluate the quality of life of patients undergoing colorectal resection for deep infiltrating endometriosis of the bowel. Questionnaires about pre operative status have been submitted retrospectively, while post operative questionnaires have been submitted prospectively during last follow up visit

Read the detailed description

All patients fit for the study will be asked to complete a visual analogue scales (VAS) for dysmenorrhea, deep dyspaurenia, dysuria, dyschesia and chronic pelvic pain (CPP) Patients will fill in the Endometriosis QoL Questionnaire (EHP30), the gastrointestinal well-being questionnaires Bristol Stool Chart, GSCG (Gastrointestinal Symptom Rating Scale), STAY (1 and 2), the Psychological General Well-Being Index (PGWBI), Generalized Self-Efficacy, CD-RISC - Connor-Davidson scale about their pre operative and actual status.

Surgery includes laparoscopic resection of all visible endometriosis, including resection of the affected bowel with primary anastomosis Perioperative and post-operative complications will be collected using the Extended Clavien-Dindo classification of surgical complications divided in early (within 30 days after surgery onset) and late (over 30 days after surgery onset).

Conditions
Endometriosis
Being tested
colorectal resection
Keywords
deep infiltrating endometriosis, colorectal resection, quality of life
Medical subject headings
Endometriosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • colorectal resectionProcedure or surgery

    Also called ileostomy creation

    Surgery includes laparoscopic resection of all visible endometriosis, including resection of the affected bowel with primary anastomosis

Study groups in NCT03824054
Study groupRoleWhat they receive
colorectal resection armPatients affected by symptomatic deep infiltrating endometriosis involving the bowel and submitted to colo-rectal resection
Receives: Procedure: colorectal resection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pre-post colorectal resection-and-anastomosis evaluation of gastrointestinal symptoms (stipsi, dyschezia, regurgitation, nausea and vomit, abdominal distension and belching)

    Pre-post colorectal-resection-and-anastomosis evaluation (mean difference or percentage variation) of stipsi, dyschezia, regurgitation, nausea and vomit, abdominal distension and belching, through the administration of the GSRS (Gastrointestinal Symptom Rating Scale) to patients. The GSRS is a disease-specific instrument that includes 15 items combined into five-symptom clusters addressing different gastrointestinal symptoms. The five-symptom clusters depict reflux, abdominal pain, indigestion, diarrhoea and constipation. The GSRS has a seven-graded scale where 1 represents absence of bothersome symptoms and 7 represents very bothersome symptoms

    Measured: from surgery to last follow up visit (which varies from 12 months to a maximum of 157 months)

Secondary outcomes (6)
  1. Pre-post colorectal resection-and-anastomosis evaluation of anxiety, depression, positivity and well-being, self control, general health and vitality

    Pre-post colorectal-resection-and-anastomosis evaluation (mean difference or percentage variation) of anxiety, depression, positivity and well-being, self control, general health and vitality, through the administration of the PGWBI (Psychological General Well-Being Index) to patients. The PGWBI is a brief self-administered questionnaire which contains 20 items rated on a six-point scale, where a higher score indicates a better quality of life and measures six mood states (anxiety, depressed mood, positive well-being, self-control, general health, vitality). The six mood states are scored as follows: 25 for anxiety, 20 for positive well-being and vitality and 15 for remaining

    Measured: from surgery to last follow up visit (which varies from 12 months to a maximum of 157 months)

  2. Pre-post colorectal resection-and-anastomosis evaluation of the coping ability of daily living

    Pre-post colorectal-resection-and-anastomosis evaluation (mean difference or percentage variation) of the coping ability of daily living, through the administration of the GSE (General Self-Efficacy Scale) to patients.

    The GSE consists of 10 items, with a 4-point Likert scale ranging from 1 (I Completely Disagree) to 4 (I Completely Agree), aimed at identifying, as expressed in the introduction, self-efficacy beliefs in view of difficult situations

    Measured: from surgery to last follow up visit (which varies from 12 months to a maximum of 157 months)

  3. Pre-post colorectal-resection-and-anastomosis evaluation of patients ability to "thrive in the face of adversity"

    Pre-post colorectal-resection-and-anastomosis evaluation (mean difference or percentage variation) of the ability to "thrive in the face of adversity", through the administration of the CD-RISC (Connor-Davidson Resilience Scale) to patients.

    The CD-RISC contains 25 items, all of which carry a 5-point range of responses, as follows: not true at all (0), rarely true (1), sometimes true (2), often true (3), and true nearly all of the time (4). The scale is rated based on how the subject has felt over the past month. The total score ranges from 0-100, with higher scores reflecting greater resilience

    Measured: from surgery to last follow up visit (which varies from 12 months to a maximum of 157 months)

  4. Pre-post colorectal resection-and-anastomosis evaluation of the effects that endometriosis can have on women's lives (includes work and family life, sexual life, fertility issues)

    Pre-post colorectal resection-and-anastomosis evaluation of the effects that endometriosis can have on women's lives (work and family life, sexual life, fertility issues), through the administration of the EHP-30(Endometriosis Health Profile questionnaire).The EHP-30 consists of a 30-item core questionnaire, covers five subscales (11 items on pain, 6 on control and powerlessness, 6 on emotions, 4 on social support, 3 on self-image), and a second 23-item modular questionnaire contains six subscales (5 items on work life, 2 on relationship with children, 5 on sexual intercourse, 4 on medical profession, 3 on treatment and 4 on infertility). Response categories are rated on a five-point Likert scale (0-4), and items within each subscale are summed to create a raw-score.Each raw scale is translated into a score ranging from 0(best possible health status) to 100 by dividing the total raw scores in each subscale by the maximum possible raw-score within the subscale and multiplying it by 100

    Measured: from surgery to last follow up visit (which varies from 12 months to a maximum of 157 months)

  5. Pre-post colorectal-resection-and-anastomosis evaluation of the menstrual pain

    Pre-post colorectal-resection-and-anastomosis evaluation (mean difference or percentage variation) of the menstrual pain, through the administration of the VAS (Visual Analogic Scale) to patients. The VAS using a 10-cm line represented the continuum of the patient's opinion of the degree of pain. One extremity of the line represented "unbearable pain," and the other extremity represented "no pain at all." The participants were asked to rate the degree of pain by making a mark on the line. The scores received from the scale were classified into mild dysmenorrhea if it was between 1 and 3 points moderate between 4 and 7 points, and severe between 8 and 10 points

    Measured: from surgery to last follow up visit (which varies from 12 months to a maximum of 157 months)

  6. Prevalence of post-operative complications (rectovaginal fistulae, bowel leakage, pelvic abscesses, and postoperative bleeding)

    Perioperative and post-operative complications were collected using the Extended Clavien-Dindo classification of surgical complications divided in early (within 30 days after surgery onset) and late (over 30 days after surgery onset). Major complications were defined as those requiring surgical, endoscopic, or radiological intervention (grade III or higher according to the Clavien-Dindo classification), and include rectovaginal fistulae, bowel leakage, pelvic abscesses, and postoperative bleeding after surgery. Minor complications were defined as those that could be solved with a conservative approach (Clavien-Dindo grade I and II)

    Measured: from surgery to last follow up visit (which varies from 12 months to a maximum of 157 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Jan 2019
  2. Study start1 Oct 2005
  3. Primary completion30 Nov 2017
  4. Study completion30 Nov 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03824054
Sponsor's protocol ID
CICOG-31-10-18\100
Acronym
ENDO-RESECT
Status last verified
Mar 2019
First submitted
2 Dec 2018
Last updated
28 Mar 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Turco LC, Scaldaferri F, Chiantera V, Cianci S, Ercoli A, Fagotti A, Fanfani F, Ferrandina G, Nicolotti N, Tamburrano A, Vargiu V, Scambia G, Cosentino F. Long-term evaluation of quality of life and gastrointestinal well-being after segmental colo-rectal resection for deep infiltrating endometriosis (ENDO-RESECT QoL). Arch Gynecol Obstet. 2020 Jan;301(1):217-228. doi: 10.1007/s00404-019-05382-8. Epub 2019 Nov 22.

    PubMed 31758304

Questions about this trial

What is this clinical trial studying?

An observational study of Endometriosis, run by Catholic University of the Sacred Heart 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 3 inclusion and 5 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 Mar 2019. 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?

Pre-post colorectal resection-and-anastomosis evaluation of gastrointestinal symptoms (stipsi, dyschezia, regurgitation, nausea and vomit, abdominal distension and belching) (time frame: from surgery to last follow up visit (which varies from 12 months to a maximum of 157 months)). 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 NCT03824054, which also lists 1 linked publication.

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 Mar 2019.

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