{"paper_id":"1ec6b5c3-156f-41bb-86de-db47bc6b75ab","body_text":"INTRODUCTION \nReview question / Objective: In recent \nyears, laparoscopy has gradually replaced \nopen surgery with its advantages of \nminimal invasiveness, fewer complications, \nand fast healing, but surgical treatment \nalone still cannot solve the problem. EMs \nare called \"pelvic sandstorms\", both radical \nand conservative operations can only \nachieve the goal of reducing the removal of \nvisible lesions and restoring normal \nINPLASY 1\nInternational Platform of Registered Systematic Review and Meta-analysis Protocols\nINPLASY\nPROTOCOL\nEffect assessment of laparoscopy in \ncombination with traditional Chinese \nmedicine decoction in the treatment \nof endometriosis: A protocol for \nsystematic review and meta-analysis\nPeng, J1; Wang, R2; Ding, Z3; Song, X4.\nTo cite: Peng et al. Effect \nassessment of laparoscopy in \ncombination with traditional \nChinese medicine decoction in \nthe treatment of endometriosis: \nA protocol for systematic \nreview and meta-analysis. \nInplasy protocol 202160074. \ndoi: \n10.37766/inplasy2021.6.0074\nReceived: 21 June 2021\nPublished: 21 June 2021\nReview question / Objective: In recent years, laparoscopy has \ngradually replaced open surgery with its advantages of \nminimal invasiveness, fewer complications, and fast healing, \nbut surgical treatment alone still cannot solve the problem. \nEMs are called \"pelvic sandstorms\", both radical and \nconservative operations can only achieve the goal of reducing \nthe removal of visible lesions and restoring normal anatomical \nstructures as much as possible. The recurrence rate of \npostoperative pain or endometriosis of the ovary remains \nhigh. In traditional Chinese medicine, the corresponding \ndisease names are \"dysmenorrhea\", \"zhengren\", \"infertility\" \nand so on. There are a large number of domestic literatures \nthat Chinese medicine can e ffectively treat EMs. The \ntreatment of endometriosis with traditional Chinese medicine \nplays an effective clinical role in alleviating the pain of the \ndisease, slowing the progression of the disease, and \npreventing the recurrence of the disease after the operation, \nand has clinical advantages. \nINPLASY registration number: This protocol was registered with \nthe International Platform of Registered Systematic Review and \nMeta-Analysis Protocols (INPLASY) on 21 June 2021 and was last \nu p d a t e d o n 2 1 J u n e 2 0 2 1 ( r e g i s t r a t i o n n u m b e r \nINPLASY202160074). \nCorresponding author: \nJiahua Peng \n845878196@qq.com \nAuthor Affiliation:                  \nInstitute of Obstetrics and \nGynecology of Traditional \nChinese Medicine, Jiangxi \nUniversity of Traditional \nChinese Medicine. \nSupport: None. \nReview Stage at time of this \nsubmission: Preliminary \nsearches. \nConflicts of interest:          \nNone declared.\nPeng et al. Inplasy protocol 202160074. doi:10.37766/inplasy2021.6.0074\nPeng et al. Inplasy protocol 202160074. doi:10.37766/inplasy2021.6.0074 Downloaded from https://inplasy.com/inplasy-2021-6-0074/\n\nanatomical structures as much as possible. \nThe recurrence rate of postoperative pain \nor endometriosis of the ovary remains high. \nIn traditional Chinese medicine, the \ncorresponding disease names are \n\"dysmenorrhea\", \"zhengren\", \"infertility\" \nand so on. There are a large number of \ndomestic literatures that Chinese medicine \ncan effectively treat EMs. The treatment of \nendometriosis with traditional Chinese \nmedicine plays an effective clinical role in \nalleviating the pain of the disease, slowing \nthe progression of the disease, and \npreventing the recurrence of the disease \nafter the operation, and has clinical \nadvantages. \nCondition being studied: Modern studies \nhave shown that integrated traditional \nChinese and western medicine has a good \nclinical effect in the treatment of EMs. \nHowever, the existing domestic and foreign \nliteratures on the treatment of EMs with \nintegrated traditional Chinese and western \nmedicine are numerous and messy, lacking \nof systematic reviews and meta analysis \nresults in insufficient clinical evidence for \nthe treatment of dysmenorrhea by \nlaparoscopy and traditional Chinese \nmedicine. Through systematic evaluation of \nthe clinical e fficacy of laparoscopy \ncombined with traditional Chinese \nmedicine in the treatment of EMs, to guide \nChinese and Western doctors in the \nrational treatment of EMs and relieve the \npain of dysmenorrhea patients. In order to \nobtain conclusive evidence of the efficacy \nof laparoscopy combined with traditional \nChinese medicine in the treatment of EMs, \nthis study uses evidence-based medicine \nto find clinical randomized controlled trials \n(RCTs) studies of silver application in the \ntreatment of diabetic feet, so as to provide \nclinicians with evidence-based evidence of. \nMETHODS \nParticipant or population: Patients \ndiagnosed with EMs, the diagnosis meets \nthe guidelines of the American Society of \nReproductive Medicine (ASRM)7 diagnostic \ncriteria for endometriosis. There will also \nbe no restrictions based on gender, race, \nand the course of the disease. However, \nthe EMs combined with pelvic infections, \nendometrial polyps, intrauterine adhesions, \ncervical stenosis, uterine malformations \nand other diseases will be excluded. \nIntervention: The experimental group was \nlaparoscopic surgery combined with \nChinese medicine decoction. \nComparator: The control group was simply \nlaparoscopic surgery. \nStudy designs to be included: The type of \nliterature research is RCTs. \nEligibility criteria: We will include all \nrandomized controlled trials (RCTs) \ninvestigating laparoscopic surgery \ncombined with Chinese herbal decoction in \nthe treatment of EMs. It will be excluded if \nthe following situations are included. 1.The \noutcome indicators in the literature are not \nclear or the outcome indicators cannot be \nextracted. 2.For research and reports with \nrepeated substantive content from the \nsame unit or the same time period and \nsigned by the same author, select one of \nt h e m a s t h e t a r g e t d o c u m e n t . \n3.Interventions incompatible with the \ninclusion criteria and animal experiments. \nInformation sources: A systematic \nliterature search will be conducted at China \nNational Knowledge Infrastructure (CNKI), \nWanFang databases, VIP, SinoMed, \nPubmed, Embase, Web of Science, and the \nCochrane library. The search period limit is \nfrom the time the date of database \nestablishment to June 21, 2021. To ensure \nthe comprehensiveness of the search, \nrelevant references and conference \nliterature are also included. The search will \nidentify all randomized controlled trials to \nevaluate the effectiveness and safety of \nlaparoscopy combined with Chinese herbal \ndecoction in the treatment of EMs. \nAfterwards, the Boolean operators “OR” \nand “AND” will be used to combine the \nf o l l o w i n g s e a r c h t e r m s : “ E M s ” , \n“Endometriosis”, “Chinese medicine \ndecoction”, “traditional Chinese medicine”, \n“TCM”, “randomized controlled trial”, \n“RCT”. \nINPLASY 2\nPeng et al. Inplasy protocol 202160074. doi:10.37766/inplasy2021.6.0074 Downloaded from https://inplasy.com/inplasy-2021-6-0074/\nPeng et al. Inplasy protocol 202160074. doi:10.37766/inplasy2021.6.0074\n\nMain outcome(s): The primary outcome \nindicators include serum follicle stimulating \nhormone (FSH), luteinizing hormone (LH), \nestradiol ( E2), pregnancy rate, recurrence \nrate. \nAdditional outcome(s): An- tral follicles \ncount (AFC), ovarian volume and adverse \nreactions. \nQuality assessment / Risk of bias analysis: \nThe risk of bias in the final included studies \nwill be evaluated based on the guidelines of \nthe Cochrane Handbook for Systematic \nReviews of Interventions. The evaluation \ncriteria include 7 items: selections bias, \nperformance bias, detect bias, attrition \nbias, reporting bias, and other bias. Each \nitem will be graded into three levels: “high \nrisk”, “low risk”, and “not clear”. This work \nwill also be done independently by 2 \nreviewers. \nStrategy of data synthesis: Revman 5.3 was \nused to perform statistical analysis on the \nextracted data and draw forest maps. \nChoose appropriate statistics and \nstatistical methods according to the type of \ndata. For binary data, calculate its odds \nratio (OR) and its 95% CI. For measurement \ndata, calculate the weighted mean \ndifference (WMD) and 95% CI. \nSubgroup analysis: Subgroup analysis can \nbe conducted according to the di fferent \nsources of heterogeneity, such as the \nfollowing aspects: treatment duration, \ndisease course, underlying disease, race, \ngender, age, etc. If no clear source of \nheterogeneity can be found, only \ndescriptive analysis can be conducted. \nSensitivity analysis: If the heterogeneity \nbetween the research results is large \n(P≤0.1, I²≥50%), sensitivity analysis should \nbe used to explore the source of the \nheterogeneity. The main methods of \nsensitivity analysis are: 1. Change the \nanalysis model, when the heterogeneity is \nhigh, use the random e ffects model. 2. \nDocuments are excluded one by one. If the \nheterogeneity does not change after being \neliminated separately, the result is relatively \nrobust. If the heterogeneity of a certain \ndocument is eliminated, then this article \nmay be the source of the heterogeneity. 3. \nAccording to the different characteristics of \nthe literature, such as region, dose, etc., \nconduct subgroup analysis. \nCountry(ies) involved: China. \nKeywords: Laparoscopy; Traditional \nChinese Medicine; Endometriosis; Meta \nanalysis.  \nContributions of each author: \nAuthor 1 - Jiahua Peng. \nAuthor 2 - Ruiqi Wang. \nAuthor 3 - Zhiling Ding. \nAuthor 4 - Xin Song. \nINPLASY 3\nPeng et al. Inplasy protocol 202160074. doi:10.37766/inplasy2021.6.0074 Downloaded from https://inplasy.com/inplasy-2021-6-0074/\nPeng et al. Inplasy protocol 202160074. doi:10.37766/inplasy2021.6.0074","source_license":"CC0","license_restricted":false}