Volume 4, Issue 4 (2020)
SJMR 2020, 4(4): 208-217 |
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Ethics code: IRCT20190714044201N2
Clinical trials code: IR.IUMS.REC 1396.23.09960882
1- Sarem Fertility & Infertility Research Center (SAFIR) & Sarem Cell Research Center (SCRC), Sarem Women’s Hospital, Iran University of Medical Sciences (IUMS), Tehran, Iran , saremiat@yahoo.com
2- Lariboisière Hospital, Paris, France
3- Sarem Fertility & Infertility Research Center (SAFIR), Sarem Women’s Hospital, Iran University of Medical Sciences (IUMS), Tehran, Iran
2- Lariboisière Hospital, Paris, France
3- Sarem Fertility & Infertility Research Center (SAFIR), Sarem Women’s Hospital, Iran University of Medical Sciences (IUMS), Tehran, Iran
Abstract: (2934 Views)
Aim: This study was performed to compare the effectiveness of radical surgery and combination therapy (Sarem's Women Hospital protocol) and their costs in patients with grade IV (Severe) endometriosis.
Material and methods: In this randomized clinical trial, 44 patients with grade IV endometriosis were randomly divided into two groups. In the first group (n=19), all endometriosis lesions were completely removed by radical surgery. In the second group (n=25) no therapeutic surgery (except diagnosis) was performed and patients were included in the combination therapy treatment protocol. In this protocol (combination therapy), patients received 12 months of drug treatment with GnRH agonist (Decapeptyl 3.75 mg, IM Inj.) every 28 days. The fine adhesions or very poor remnants of endometriosis lesions removed by second-look laparoscopy. The severity of pelvic pain and dysmenorrhea was analyzed according to the VAS scale, one month and two years later, along with treatment costs in both groups.
Results: One month after the end of treatment, pelvic pain and dysmenorrhea were significantly lower in the combination therapy group, and on the other hand, two years after treatment, recurrence of dysmenorrhea and pelvic pain were significantly higher in the radical surgery group than in the combination therapy group. There were no post-treatment complications in the combination therapy group, while some patients in the radical surgery treatment group developed complications. Also in this study, it was shown that the cost of treatment in the radical surgery group was significantly higher than the combination therapy group.
Discussion and Conclusion: Combination treatment of endometriosis (Sarem's Women Hospital protocol) is more effective in reducing dysmenorrhea and pelvic pain one month and two years after treatment and with much fewer complications and is superior to radical surgery in terms of treatment costs.
Material and methods: In this randomized clinical trial, 44 patients with grade IV endometriosis were randomly divided into two groups. In the first group (n=19), all endometriosis lesions were completely removed by radical surgery. In the second group (n=25) no therapeutic surgery (except diagnosis) was performed and patients were included in the combination therapy treatment protocol. In this protocol (combination therapy), patients received 12 months of drug treatment with GnRH agonist (Decapeptyl 3.75 mg, IM Inj.) every 28 days. The fine adhesions or very poor remnants of endometriosis lesions removed by second-look laparoscopy. The severity of pelvic pain and dysmenorrhea was analyzed according to the VAS scale, one month and two years later, along with treatment costs in both groups.
Results: One month after the end of treatment, pelvic pain and dysmenorrhea were significantly lower in the combination therapy group, and on the other hand, two years after treatment, recurrence of dysmenorrhea and pelvic pain were significantly higher in the radical surgery group than in the combination therapy group. There were no post-treatment complications in the combination therapy group, while some patients in the radical surgery treatment group developed complications. Also in this study, it was shown that the cost of treatment in the radical surgery group was significantly higher than the combination therapy group.
Discussion and Conclusion: Combination treatment of endometriosis (Sarem's Women Hospital protocol) is more effective in reducing dysmenorrhea and pelvic pain one month and two years after treatment and with much fewer complications and is superior to radical surgery in terms of treatment costs.
Keywords: Endometriosis, Radical Surgery, Combination Therapy, Decapeptyl, GnRH Agonist, Dysmenorrhea, Pelvic Pain, Recurrence, Cost, Randomized Controlled Trial (RCT)
Article Type: Original Research |
Subject:
Women Diseases
Received: 2021/01/10 | Accepted: 2021/01/10 | Published: 2021/01/10
Received: 2021/01/10 | Accepted: 2021/01/10 | Published: 2021/01/10
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