Conventional Laparoscopy Versus Robotic Surgery for Pain Relief in Patients With Deep Infiltrating Endometriosis

NCT05362838 | Unknown

• 1 other identifier: TIE pain robotic vs. LSK
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Endometriosis is a common disease, affecting women in their reproductive age suffering from infertility, adnexal masses and chronic pelvic pain, obstruction of the bowel or urinary tract. Deeply infiltrating endometriosis (DIE) is defined as a solid endometriosis mass situated more than 5 mm deep to the peritoneum. These lesions are considered very active and are strongly associated with pelvic pain symptoms. Surgery is recommended in women with pain resistant to medical therapy and in women with contraindications to or refusal of medical therapy. Further indications for surgical treatment are the need of excluding malignancy in an adnexal mass, obstruction of the bowel or urinary tract. It is hypothesized that in patients with lesions in complex anatomic sites, a robot-assisted approach may provide improved instrument articulation compared with conventional laparoscopy, but no data are available. Aims: The aim of this study is to perform a pilot study investigating differences between robot-assisted laparoscopy compared to conventional laparoscopy regarding subjective symptom outcome, evaluated by VAS score for non-menstrual pelvic pain and dysmenorrhea. Study population: The study population will consist of women aged between 18 and 51 years who are referred to our gynecologic outpatient clinic due to symptomatic endometriosis. Women with suggested DIE and an indication for surgery can be included in this trial. Methods: Laparoscopic-assisted resection of endometriosis will be performed using up to five 5-mm ports, including an umbilical port and additional ports as dictated by each individual surgery. The robotic-assisted resection of endometriosis will be performed using the da Vinci Surgical System Si (Intuitive Surgical) using up to five ports as needed. Superficial and deep endometriosis resection will be performed in the usual standard fashion. Histological confirmation of endometriosis will be performed. The primary outcome is subjective symptom improvement. This will be evaluated by visual analog scale (VAS) for dysmenorrhea and non-menstrual pelvic pain on a daily basis for at least 1 calendar month before the operation to obtain adequate baseline measurements. This evaluation will be repeated 3 and 6 months after surgery.

Conditions

Endometriosis; Endometriosis-related Pain; Endometriosis Pelvic

Outcome Measures

Primary Outcomes (4)

• Change in Visual analog scale (VAS) from baseline to 3 and 6 months after the operation

  Patients will be asked to complete a VAS for dysmenorrhea and non-menstrual pelvic pain on a daily basis for at least 1 calendar month at baseline and after 3 months and after 6 months following the operation. For VAS score we will calculate the mean of the 5 days/months with the highest VAS score. Patients will be asked to write down their VAS score before taking pain medication.

  6 months after the operation

• Pain medication

  Medication being taken for endometriosis-associated pain will be assessed in this daily questionnaire (type of medication and dosage).

  6 months after the operation

• Menstrual bleeding

  Menstrual bleeding will be assessed in this daily questionnaire (yes versus no).

  6 months after the operation

• Patients' Global Impression of Change (PGIC)

  PGIC will be used to calculate the rate of responders 3 and 6 months after the operation

  6 months after the operation

Secondary Outcomes (10)

• Change in Biberoglu and Behrman (B&B) score from baseline to 3 and 6 months after the operation

  6 months after the operation

• rate of intraoperative adverse events

  1 day

• rate of postoperative adverse events

  4 weeks

• operation time

  1 day

• length of hospitalization (following the operation)

  2 weeks

Study Arms (2)

robotic-assisted laparoscopy

ACTIVE COMPARATOR

The robotic-assisted resection of endometriosis will be performed using the da Vinci Surgical System Si (Intuitive Surgical) using up to five ports as needed. An umbilical port will be placed for the laparoscope (10/12 mm), a 5-mm port for the assistant, and two to three ports (5/8 mm) for the robotic arms.

Procedure: robotic-assisted laparoscopy

conventional laparoscopy

ACTIVE COMPARATOR

Laparoscopic-assisted cystectomy of endometrioma will be performed using up to four 5-mm ports, including an umbilical port and additional ports as dictated by each individual surgery.

Procedure: Conventional laparoscopy

Interventions

robotic-assisted laparoscopy PROCEDURE

Superficial and deep endometriosis resection will be performed in the usual standard fashion. All superficial lesions suspicious for endometriosis (pigmented and nonpigmented) will be completely resected until non-diseased peritoneal margins are visualized around the defect; all deep lesions suspicious for endometriosis will be completely resected until non-diseased margins are visualized in the tissue surrounding the defect. Cystectomy will be performed for endometriomas. Additional procedures are performed as needed to completely resect all endometriosis lesions. The fascia of any port ≥10 mm will be reapproximated. If bowel resection and re-anastomosis is necessary this will be performed together with a General Surgeon.

Also known as: DaVinci laparoscopy

robotic-assisted laparoscopy

Conventional laparoscopy PROCEDURE

Superficial and deep endometriosis resection will be performed in the usual standard fashion. All superficial lesions suspicious for endometriosis (pigmented and nonpigmented) will be completely resected until non-diseased peritoneal margins are visualized around the defect; all deep lesions suspicious for endometriosis will be completely resected until non-diseased margins are visualized in the tissue surrounding the defect. Cystectomy will be performed for endometriomas. Additional procedures are performed as needed to completely resect all endometriosis lesions. The fascia of any port ≥10 mm will be reapproximated. If bowel resection and re-anastomosis is necessary this will be performed together with a General Surgeon.

conventional laparoscopy

Eligibility Criteria

• Age: 18 Years - 51 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Suspected deep infiltrating endometriosis affecting Enzian compartments A, B and C with lesions sized ≥1 (A2-3, B2-3 and C2-3)
• Mean VAS score for dysmenorrhea or non-menstrual pelvic pain \>= 5 (assessed at 5 days/ month with the heaviest symptoms)
• Surgical endometriosis resection is planned

You may not qualify if:

• History of malignant diseases
• Current systemic glucocorticoid or immunosuppressant treatment
• Subject is unable or unwilling to participate
• Postmenopausal women
• Combined oral contraception

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

Medical University of Vienna, Department of Obstetrics and Gynecology

Vienna, 1090, Austria

RECRUITING

MeSH Terms

Conditions

Endometriosis

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Rene Wenzl, Prof

  Medical University of Vienna, Department of Obstetrics and Gynecology

  STUDY DIRECTOR

Central Study Contacts

Christine Bekos, Dr

CONTACT

004369913536030; christine.bekos@meduniwien.ac.at

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: May 3, 2022
• First Posted: May 5, 2022
• Study Start: April 1, 2022
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: June 8, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)