The Effect of New Cross Linked Hyaluronan Gel on Quality of Life of Patients After Deep Infiltrating Endometriosis Surgery: A Randomized Controlled Pilot Study

A prospective 1:1 randomised placebo-controlled study was conducted in our department during the study period January 2017-January 2019. All patients were included after obtaining written, signed informed consent before participating. All of the procedures were performed by the same surgery team who are experienced in minimally invasive (Deep infiltrating endometriosis) DIE surgery. The study protocol was approved by the local Ethics Committee of hospital (Approval number: 2017/04/35) 60 patients who were underwent for laparoscopic surgery for the treatment of deep infiltrating endometriosis without bowel involvement were recruited.

The inclusion criteria for this study were as follows, aged 18 to 45 years, and undergoing laparoscopic surgery for suspicious of DIE and persistent pain irrespective to any medical treatment. Patients were booked for follow-up visits at the 3rd and 6th month postoperative months and wanted to fill the questionnaires.

The exclusion criteria for the study were as; acute or severe infection, autoimmune disease, known/suspected intolerance or hypersensitivity to Hyaluronan or its derivatives, concurrent use of a systemic anti-inflammatory or hormonal drug at least 3 months prior to the surgery, clinical evidence of cancer; use of anticoagulant, fibrin glue, other thromboembolic agents, or any other anti-adhesion agent during the procedure ,patients with surgically diagnosed bowel involvement or need bowel resection, and who want to receive any postoperative hormonal treatment.

Participants were allowed to voluntarily withdraw from the trial for any reason at any time, and could be terminated by investigators owing to safety concerns, violations of inclusion/exclusion criteria, or pregnancy.

Surgical procedure The patients were laid low lithotomy position under general anesthesia. Patients were assigned at random to either the NCH gel or control group in a 1:1 ratio through a computer based program. A standardised technic with 4 abdominal incision laparoscopic approach with 10 mm umbilical trocar for the optic camera and three 5 mm axillary ports for the surgical instruments were used. All of the surgeries initiated from exploring the pelvic cavity, identification of the ureters and dissection transection of the pelvic adhesion by 5 mm bipolar cautery used at 25 kw for coagulation mode and scissors. The incision was begun on the left pelvic sidewall just cephalad to the last deposit. The incision was then extended towards the uterus, lateral and parallel to the left uterosacral ligament. The uterosacral ligament was pushed medially and down and the healthy tissues including the ureter were pushed upwards and laterally away from the dissection. It then transected the right utero-sacral ligament and was continued along the right pelvic sidewall just lateral and above the right uterosacral ligament until it extends beyond all obvious deposits. All of the endometriotic foci was grasped and pulled then undercut and freed so that the whole lesion and a surrounding margin of healthy tissue was removed. After an extensive bleeding control the Patients in the intervention group had 40 mL of HyaRegen NCH gel instilled into the peritoneal cavity through a large-bore cannula following standard laparoscopic procedures. The patients in the control group had 40 cc sterile saline solution compatible with the body temperature. Operators could not be blinded to treatment allocation, but the questionnaire assessors and the patients were blinded to treatment allocation.