Dataset Information

Relapse after conservative surgery combined with triptorelin acetate versus conservative surgery only in women with focal adenomyosis: study protocol for a multicenter, prospective, randomized controlled trial.

ABSTRACT:

Background

The preservation of fertility and integrity of the reproductive organs has increasingly been of concern to most women with adenomyosis. Adenomyomectomy is conservative surgery that is now widely applied; however, relapse is a serious problem after the operation. Postoperative treatment, such as gonadotropin-releasing hormone agonist (GnRHa) has been suggested to result in reducing the rate of disease recurrence. However, there is still a lack of evidence from randomized clinical trials examining the efficacy of GnRHa in decreasing the postoperative recurrence rate.

Method/design

Relapse after conservative surgery combined with triptorelin acetate versus conservative surgery only in women with focal adenomyosis is a multicenter, prospective, randomized controlled trial. The primary outcome is relapse assessed using a visual analogue scale (VRS) and numeric rating scale (NRS), pictorial blood loss assessment chart (PBAC) score, and the size of the uterus and the lesion as measured by two/three-dimensional color doppler ultrasonography (2D/3D-CDUS) or magnetic resonance imaging (MRI). The secondary outcomes include quality of life, clinical pregnancy, ovarian reserve, adverse events, assessment by the Short Form (36) Health Survey and Female Sexual Function index, serum follicle-stimulating hormone, estradiol levels, and anti-Muellerian hormone and so on. All these indexes are measured at 3, 6, 12, 18, 24, 30, and 36?months after conservative surgery.

Discussion

The result of this large, multicenter randomized trial will provide evidence for one of the strategies of long-term management in focal adenomyosis after conservative operation.

Trial registration

Chinese Clinical Trial Registry: ChiCTR1800014340. Registered on 6 January 2018.

SUBMITTER: Wang W

PROVIDER: S-EPMC7189466 | biostudies-literature | 2020 Apr

REPOSITORIES: biostudies-literature

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Publications

Relapse after conservative surgery combined with triptorelin acetate versus conservative surgery only in women with focal adenomyosis: study protocol for a multicenter, prospective, randomized controlled trial.

Wang Wenwen W Ma Xiangyi X Zhang Wei W Li Zhiying Z Wang Yan Y Yu Zhiying Z Zhang Chunlian C Hong Li L Luo Ruoyu R Xing Hui H Wang Wuliang W Yue Qingfen Q Wei Jia J Zhang Minli M Wang Shixuan S

Trials 20200428 1

<h4>Background</h4>The preservation of fertility and integrity of the reproductive organs has increasingly been of concern to most women with adenomyosis. Adenomyomectomy is conservative surgery that is now widely applied; however, relapse is a serious problem after the operation. Postoperative treatment, such as gonadotropin-releasing hormone agonist (GnRHa) has been suggested to result in reducing the rate of disease recurrence. However, there is still a lack of evidence from randomized clinic ...[more]

PMID: 32345377

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Project description:AbstractTriptorelin has been used after surgery in deep infiltrating endometriosis. This post-hoc analysis aimed to evaluate symptom control between patients receiving 1-3 triptorelin injections and those receiving 4-6 injections within 24 months of conservative surgery for deep infiltrating endometriosis, in the real-world.Included patients were divided into two groups (received up to 3 months injections in group A, 4-6 injections in group B) based on the numbers of triptorelin (Diphereline, 3.75 mg intramuscular injection once every 28 days for up to 24 weeks) administration. Evolution in score of pain intensity at 3, 6, 9, 12, 18, and 24 months after primary triptorelin administration and symptom improvement/recurrence rates between two groups were compared. Symptoms of pain intensity were assessed using a visual analogue scale (VAS) with a range from 0 to 10 cm. An improvement in symptoms was defined as a reduction of at least 3 cm or 3 units from pre-surgery levels.156 patients in group A and 228 in group B. Pain symptom score (mean ± standard deviation) diminished to a nadir at 3-months for group A and 6-months for group B; at 6-months nadir scores were significantly lower in group B (0.9 ± 1.7 vs 0.4 ± 1.2 respectively, P = .002). No significant difference for pain symptom scores between both groups at 24-months (P = .269). The 6-month and 24-month cumulative improvement rates of pain (80.6% vs 89.8%, P = .014 and 82.6% vs 90.7%, P = .025) and gastro-intestinal symptoms (61.0% vs 80.8%, P = .022 and 61.0% vs 83.3%, P = .008) were significantly higher in group B, whereas there was no significant difference in rates of menstrual disorders and urinary symptoms. There is no significant difference for 12-months and 24-months cumulative recurrence rates of total symptoms between both groups (11.3% vs 13.8%, P = .568 and 16.1% vs 26.0%, P = .094).In women with deep infiltrating endometriosis, longer treatment with triptorelin following conservative surgery was associated with a decrease in symptom intensity and greater improvement of pain symptoms in the short-term and greater improvement of gastro-intestinal symptoms in the long-term.Trial registration number: ClinicalTrials.gov, NCT01942369.

Project description:BackgroundPostoperative upper gastrointestinal fistula (PUGIF) is a devastating complication, leading to high mortality (reaching up to 80%), increased length of hospital stay, reduced health-related quality of life and increased health costs. Nutritional support is a key component of therapy in such cases, which is related to the high prevalence of malnutrition. In the prophylactic setting, enteral nutrition (EN) is associated with a shorter hospital stay, a lower incidence of severe infectious complications, lower severity of complications and decreased cost compared to total parenteral nutrition (TPN) following major upper gastrointestinal (GI) surgery. There is little evidence available for the curative setting after fistula occurrence. We hypothesize that EN increases the 30-day fistula closure rate in PUGIF, allowing better health-related quality of life without increasing the morbidity or mortality.Methods/designThe NUTRILEAK trial is a multicenter, randomized, parallel-group, open-label phase III trial to assess the efficacy of EN (the experimental group) compared with TPN (the control group) in patients with PUGIF. The primary objective of the study is to compare EN versus TPN in the treatment of PUGIF (after esophagogastric resection including bariatric surgery, duodenojejunal resection or pancreatic resection with digestive tract violation) in terms of the 30-day fistula closure rate. Secondary objectives are to evaluate the 6-month postrandomization fistula closure rate, time of first fistula closure (in days), the medical- and surgical treatment-related complication rate at 6 months after randomization, the fistula-related complication rate at 6 months after randomization, the type and severity of early (30 days after randomization) and late fistula-related complications (over 30 days after randomization), 30-day and 6-month postrandomization mortality rate, nutritional status at day 30, day 60, day 90 and day 180 postrandomization, the mean length of hospital stay, the patient's health-related quality of life (by self-assessment questionnaire), oral feeding time and direct costs of treatment. A total of 321 patients will be enrolled.DiscussionThe two nutritional supports are already used in daily practice, but most surgeons are reluctant to use the enteral route in case of PUGIF. This study will be the first randomized trial testing the role of EN versus TPN in PUGIF.Trial registrationClinicalTrials.gov: NCT03742752. Registered on 14 November 2018.

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Project description:BACKGROUND:The structures of the mesentery including adipose tissue, nerves, and lymphatics play an important role in the pathogenesis and disease progression of Crohn's disease (CD). Conventional surgical resection for CD usually does not involve resecting the mesentery en bloc with the specimen. This contrasts with complete mesocolic excision (CME) in colorectal cancer, which involves radical resection of the mesentery. Preliminary evidence from smaller studies suggests that applying the principle of mesocolic excision to CD surgery may reduce the risk of postoperative recurrence. This randomized controlled trial is designed to test whether applying the principles of mesocolic excision to CD results in reduced postoperative recurrence. It also aims to evaluate intra- and postoperative morbidity between the two approaches. METHODS:This international, multicenter, randomized controlled trial will randomize patients (n?=?116) scheduled to undergo primary ileocolic resection to either receive extensive mesenteric excision (EME) or conventional ileocolic resection with limited mesenteric excision (LME). Five sites will recruit patients in three countries. In the EME group, the mesentery is resected following CME, while avoiding the root region, i.e., 1?cm from the root of the ileocolic artery and vein. In the LME group, the mesentery is retained, i.e., "close shave" or?<?3?cm from the border of bowel. The primary end point will be surgical recurrence after surgery. The secondary end points will be the postoperative endoscopic and clinical recurrence, and intra- and postoperative morbidity. Demographics, risk factors, laboratory investigations, endoscopy, postoperative prophylaxis and imaging examination will be assessed. Analysis of the primary outcome will be on an intention-to-treat basis. DISCUSSION:If mesocolic excision in CD reduces postoperative disease recurrence and does not increase morbidity, this trial has the potential to change practice and reduce recurrence of CD after surgical resection. TRIAL REGISTRATION:Clinical Trials.gov, ID: NCT03769922. Registered on February 27, 2019.

Dataset Information

Relapse after conservative surgery combined with triptorelin acetate versus conservative surgery only in women with focal adenomyosis: study protocol for a multicenter, prospective, randomized controlled trial.

Background

Method/design

Discussion

Trial registration

Publications

Relapse after conservative surgery combined with triptorelin acetate versus conservative surgery only in women with focal adenomyosis: study protocol for a multicenter, prospective, randomized controlled trial.

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