ARTICLE INFO

Article Type

Original Research

Authors

Saremi   A.T. (*)
Pooladi   A. (1)






(*) ‎“Sarem Fertility & Infertility Research Center (SAFIR)” and “Sarem Cell Research Center (SCRC)” ‎, Sarem Women’s Hospital, Tehran, Iran
(1) Sarem Fertility & Infertility Research Center (SAFIR) and Sarem Cell Research Center (SCRC) and Medical ‎Genetics Department‎, Sarem Women’s Hospital, Tehran, Iran

Correspondence

Article History

Received:  April  26, 2017
Accepted:  October 6, 2017
ePublished:  November 15, 2018

BRIEF TEXT


The classic definition of endometriosis is the presence of the uterine endometrium tissue in a place out of uterus that is a chronic disease in women. It is one of the most common diseases in the reproductive system of women throughout the world.

The classic definition of endometriosis is the presence of the uterine endometrium tissue in a place out of uterus that is a chronic disease in women. It is one of the most common diseases in the reproductive system of women throughout the world.

Since there is still no definitive treatment for endometriosis, the need to develop and complete ‎endometriosis treatment strategies is now well understood. Accordingly, the aim of this study was to ‎investigate the effect of the new therapeutic program of endometriosis in the form of a drug-surgical ‎combination.‎

This is a non-experimental interventional study.‎

Patients with proven endometriosis, among the patients referred to the Sarem Hospital in Tehran, were ‎examined during the period from April 2011 to April 2013.‎

‎47 patients with confirmed endometriosis were evaluated.‎

None of the patients were involved in invasive invasion of rectal and bladder tissue. In the early ‎laparoscopy of endometriosis, the disease progression was carried out in accordance with the ‎modified system of endometriosis classification of the American Society of Reproductive Medicine ‎‎(ASRM) [20]. Grouping of patients was performed based on four stages of severity of endometriosis, ‎including stage I (10 patients), stage II (22 patients), stage III (10 patient) and stage IV (5 patients). ‎Complete information was provided to the patients about the treatment process by providing the ‎necessary explanations and accordingly, they signed the informed consent card. This study began with ‎the submission of sufficient evidence and its follow-up after obtaining written permission from the ‎morality committee of the Sarem Hospital, No. 877-8909 dated 9/29/2010. The study was started in ‎April 2011.‎ The treatment process included the patient's entry into the study and then the implementation of the ‎treatment protocol in view of the severity of the recorded endometriosis lesions based on their first ‎diagnostic laparoscopy. After a period of drug therapy (with a specific length according to the ‎instructions described below), the patient was subjected to secondary laparoscopy and, in addition to ‎registering the progression or regression of the disease, his next program for continuing drug therapy, ‎surgical intervention (laparoscopy or laparotomy) or a third laparoscopy after continued medication ‎‎(for severe endometriosis included stages III-IV) were determined.‎ In the early laparoscopy, any adhesion and removable lesion was removed by electrocoagulation and ‎the patient was treated with a GnRH agonist for a specified period (such as decaptopyle 375 mg per ‎month). Based on drug recommendations and drug immunity and side effects for endometriosis, for ‎stage I, 3 months of medication and for stage II, in the first step 3 months and if necessary (based on ‎laparoscopy), another 3 months of continued treatment, and for stage III, first 6 months of ‎administration of decapeptide and based on secondary laparoscopy, continued injection for another 3 ‎months were considered. For stage IV, this number was initially 9 months, along with laparoscopic ‎follow-up and treatment, that injection was continued for another 3 months if necessary [21-26]. Add-‎Back Therapy with Combined Pregnancy Pills (OCP) was considered for candidates for drug treatment ‎for more than 3 months, and OCP has been included in their drug prescriptions [27]. Third laparoscopy ‎was indicated only for severe degrees of endometriosis that did not disappear with the early stages of ‎treatment (including stages III, IV). In step IV, an initial laparoscopy was performed without any ‎manipulation of the design and removing the adhesions was postponed to the second laparoscopy ‎‎(and, if necessary, the third).‎

The mean age of patients was 30.8 ± 4.4 years (Table 1). The results of the response to treatment in ‎stage I with 3 months of GnRH analogue therapy and primary laparoscopic intervention included 9 ‎‎(90.0%) patients, and the remaining symptoms were resolved by continuing treatment for another 3 ‎months. Secondary laparoscopy was not ethically allowed for this group. The response to treatment in ‎stage II with 3 months of GnRH analogy and early laparoscopic intervention was 10 (45.5%), which ‎seemed insufficient, and for more than half of the patients, the injection of GVRH-a was continued ‎following the initial laparoscopy; Totally, after 6 months of treatment, the response rate reached 16 ‎‎(72.7%). Other people were also selected for continued treatment for another 3 months, with ‎symptoms improved according to follow-up. For this group, for reasons of ethics and non-indication, ‎third laparoscopy was not allowed, especially since the initial complaints of patients were resolved. In ‎the third stage, the response to drug therapy with 6 months of decapeptyl injection was effective in 5 ‎‎(50.0%) patients, and the remaining individuals showed a significant improvement in post-operative ‎laparoscopy. Only one patient remained for the continuation of drug therapy and third laparoscopy. In ‎patients with stage IV, after 9 months of continuous drug therapy, with secondary treatment of ‎laparoscopy for removing lesions and adhesions, and continuing treatment for another 3 months, 2 ‎‎(40.0%) patients recovered in third laparoscopy, and the remaining 3 cases with 3 months of ‎additional treatment did not respond to the third laparoscopy as well and were undergone laparotomy. ‎The total number of patients with the first treatment period was 26 (55.3%). The frequency and ‎percentage of recovered patients with the second treatment period was 31(66%), and the frequency ‎and cumulative percentage of the total number of recovered patients including continuation of ‎treatment was 42(89.4%).‎

Compared with the findings of other studies, surgical treatments with a total success rate of up to 80% ‎‎[28, 29] or a medication with a total success rate of 50% to 70% [16, 29-31] have been used alone, or ‎limited proposed combination therapies have had overall success 70% -85% [29, 32-34]. It seems that ‎the present study has achieved a higher success rate.‎ The planning logic and protocol for managing endometriosis as a primary surgical intervention in the ‎first laparoscopy (except for a stage of the disease), and then the analogue GnRH injection with defined ‎periods, and the continuation of each course of treatment (if not responding to the initial treatment) for ‎‎3 months, seems to be empirically acceptable. This design was based on previous studies [5, 12, 13, ‎‎18, 32, and 33] that in other studies, some evidence of the impact of these therapeutic courses and ‎interventions, both in form of laparoscopic surgery [14, 20, 22, 23 ] and in form of drug therapy [17, ‎‎18] have been observed.‎ Naturally, endometriosis is more likely to require more aggressive treatments and a longer course of ‎treatment. The important thing in this therapeutic process is the possibility of prolonging GnRH ‎analogue therapy, which is avoided by most experts, while it does not have serious and severe ‎complications for the patient, and through the recommended methods of add-back therapy, these ‎complications can be controlled [35]. These supportive treatments are recommended for periods of ‎more than 3 months.‎

It seems that the study of the effectiveness of this treatment protocol in the process of success of ‎supportive care for infertile people is necessary.‎

One of the limitations of this study is the lack of definitive and objective confirmation of improvement ‎in stages I and II through laparoscopy for ethical reasons, because in the two groups of patients in ‎stages I and II in this study, the final improvement has been evaluated based on patient satisfaction and ‎the improvement of clinical symptoms, and not based on the definitive evidence with laparoscopic ‎vision that the abdominal cavity has been cleaned. In addition, due to the self-limiting nature of the ‎disease and improvement in milder degrees to about one-third of cases [29], it is logical to not impose ‎additional laparoscopy on these patients.‎ ‎

After initial primary laparoscopy (diagnosis-therapy), at stage I, at least 3 months of GnRH analogue ‎therapy is needed. In stage II, 6 months of injection and in stage III, 6 months of injection (followed by ‎post-laparoscopic follow up) for up to 9 months of treatment, results in recovery in most patients and ‎in stage IV, without manipulation of primary surgery, by 9 months of treatment with injection and ‎another 3 months treatment after the second laparoscopy, a part of the patients can be managed. The ‎continuation of treatment in each group depends on clinical symptoms and follow-up laparoscopy. ‎





Complete information was provided to the patients about the treatment process by providing the ‎necessary explanations and informed consent sheet was received. This study was carried out with ‎sufficient evidence after receiving written permission from the ethics committee of Sarem Hospital in ‎Tehran, no. 8909-877 dated December 11, 2010.‎



TABLES and CHARTS

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