International Journal of Medicine and Biosciences

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1 ISSN Int J Med Biosci. 2013; 2(1): International Journal of Medicine and Biosciences A comparative study on complications of double puncture laparoscopic sterilization and conventional tubal ligation methods Sudhir Babu Palli 1* and Vijaja Lakshmi Akkupalli 2 1 *Department of Obstetrics and Gynaecology 2 Department of Physiology Viswabharathi Medical College and General Hospital, Kurnool, Andhra Pradesh, India Received 28 November 2o12; accepted 25 December 2012; published online 31 January 2013 Research Article Internal Medicine Abstract To compare the complications between the double puncture laparoscopic and conventional tubal ligation sterilization methods. There are 1000 acceptors were divided equally into two groups : 500 women underwent double puncture laparoscopic (DPL) sterilization and another 500 women undergone conventional tubal ligation (CTL). Both the groups were followed up for the period of two years. Each acceptor was personally interviewed and consent taken before the procedure. The interview was performed by multipurpose health workers of the particular rural areas. The mean age of DPL and CTL group were 24.4 years and 23.8 years respectively. Overall major morbidity in DPL acceptors was 1.6 when compared to CTL acceptors which was 1. The minor morbidity in DPL acceptors was low (8) in comparison with CTL acceptors (14.4). The DPL procedure was clearly advantageous than the conventional tubal ligation procedure in terms of complications. Key words: DPL, CTL, complications, morbidity Introduction The most serious problem India is facing today is the rapid growth of its population. As per recent census (2011) the population of India is 1.22 billion. Over populated countries like India depend mainly on sterilization to control population explosion. Even though there are wide ranges of contraceptive options available, tubal sterilization is currently the most popular form of birth control. It is an important constituent of National Family Planning Program in India. Tubal sterilization is being done from primary health center to the tertiary care centers in the government sector and also at private institutions and nursing homes. According to NFHS-3 ( ), female sterilization accounted for 37.3 of all methods of family planning used in the country [1]. This is influenced by the economic compensation being given and according to a survey data, 64 women stated, they would like to go for tubal sterilization at some time in future [2,3]. *Corresponding Author magadhira@gmail.com Copyright 2012, International Journal of Medicine and Biosciences All Rights Reserved There are two common methods for female sterilization: Double puncture laparoscopic technique (DPL) and conventional tubal ligation (CTL). Both the methods are associated with complications. Laparoscopic sterilization is considered superior to traditional surgical procedure and there is an increase of acceptance of laparoscopic sterilizations. Hence the objectives of this study to compare the complications, both the immediate and delayed in double puncture laparoscopic tubal ligation and conventional tubal ligation. Materials and Methods A follow-up prospective study of laparoscopic sterilization (DPL) and conventional tubectomy (CTL) in Family Planning Unit, Government Maternity hospital, Tirupati, A.P. India was undertaken ( January March 2003). A 500 voluntary conventional tubectomy accepters and 500 Voluntary DPL acceptors were selected and operated. The selection criteria was strictly followed, so as not to interfere with the interpretation of results as most of the morbidity or complications could arise because of preexisting condi-

2 Sudhir Babu & Vijaja Lakshmi / Int J Med Biosci. 2013; 2(1): tions like MTP, Hysterotomy, LSCS, menstrual disorders etc. The cases were personally attended during the procedure and followed up post operatively and complications noted as per the guidelines in the proforma. All cases were personally interviewed at their door steps with the guidance of multipurpose health workers of the area concerned in the rural areas and in urban areas with the help of ANM s welfare workers of post-partum unit in Government Maternity Hospital, Tirupati, AP, India. Questionnaire was originally prepared in English and were translated into local language. The interviewers selected were ANM s of postpartum unit and were trained to the level of satisfaction and allowed to conduct the survey. Results A comparative study of 1000 cases with 500 patients each for DPL and CTL acceptors was undertaken. In age group of years, 83.4 were DPL acceptors and 81 were CTL acceptors whereas, in age group above 31 years old, 3.8 selected DPL and 48 accepted CTL. The mean age groups for DPL and CTL accepters were 24.4 and 23.8, respectively. The overall mean age was 24.1 years (Table 1). The data reveals that overall major morbidity in DPL acceptors was 1.6 which was higher than the CTL acceptors (1). In intraoperative complications, the leading major morbidity of DPL group was bowel injuries (0.4), while CTL group had bladder injuries (0.4) ( Table 2). Regarding the postoperative complications, overall major morbidity in DPL acceptors are 1.6 which is higher than CTL acceptors (1). The leading major morbidity in DPL group was bowel injuries as bladder injuries lead in CTL group (Table 3). The data revealed that two acceptors, one from each group, were admitted for ectopic pregnancy and the major morbidity for both group was equal i.e. 2 (Table 4). The minor morbidity in DPL acceptors was 8 which was lower than the conventional tubectomy acceptors (14.4). 20 of DPL group had intra operative complications, whereas only 2 of CTL group had complications. Regarding the postoperative complications, CTL group had 62 patients (12.4) had complications, while only 20(4) had complications. This clearly shows superiority of DPL procedure over the CTL method with regards to minor complications (Table 5 and Table 6). The overall morbidity for both acceptors are The conventional tubectomy acceptors were having more complaints i.e. 45 compared to the DPL acceptors (34). Age DPL CTL Total No.of Below 20 Years Years Years Years Years Total No.of & Table. 1. Distribution of DPL and CTL Acceptors according to Age

3 Sudhir Babu & Vijaja Lakshmi / Int J Med Biosci. 2013; 2(1): Complication DPL CTL Total Intraperitoneal haemorrhage Injury to bladder Injury to bowel No complications Total & Table. 2. Comparison of Major morbidity - Intra Operative Complications for DLP and CTL groups Complication DPL CTL Total Peritonitis Surgical Emphysema Wound sepsis Distension of Abdomen No complications Total No.of & Table. 3. Comparison of Major Morbidity- Post Operative Complications in DPL and CTL groups

4 Sudhir Babu & Vijaja Lakshmi / Int J Med Biosci. 2013; 2(1): Complications DPL CTL Total Complaints Ectopic Pregnancy Total no of & (percentage) Table. 4. Comparison of Major Morbidity for delayed complications Complication DPL Con Tubectomy Total Subcutaneous emphysema Intraperitoneal haemorrhage Mesenteric tear Omental prolapsed Cardio Respiratory Embarrassment No complications Total complications Total & Table. 5. Minor Morbidity-Intra Operative Complications

5 Sudhir Babu & Vijaja Lakshmi / Int J Med Biosci. 2013; 2(1): Complications DPL Con Tubectomy Total Wound Sepsis Abdominal Wall Haematoma Surgical Emphysema Shoulder Pain Distension of Abdomen Pyrexia Vomtings Pain Abdomen No Complications Total no of complications Table. 6. Minor morbidity - Post Operative Complications Figure. 1. Minor Morbidity for delayed Complications

6 Sudhir Babu & Vijaja Lakshmi / Int J Med Biosci. 2013; 2(1): Complications DPL CTL Total No Complications Menstrual Irregularities White Discharge Low Back Ache Lower Abdominal Pain General Weakness Easy Fatigability PID Dyspareunia Weight gain Weight loss Scar Tenderness Miscellaneous Table. 7. Minor Morbidity for delayed Complications The overall menstrual irregularities in both acceptors was 16 -the CTL group had 18.8,whereas DPL group had The incidence of women suffering from white discharge was slightly higher in DPL group (25.6) when compared to CTL group (25.2). The incidence of backache was higher in CTL acceptors (33.4) compared to DPL group (24.4). Moreover the lower abdominal pain was more in CTL group (14.4) compared to DPL acceptors (9.6). Besides, other minor complications like fatigue was higher in CTL group (12.6) than the DPL group (10.4) (Table 7 and Figure 1) Discussion 1000 acceptors are divided into two groups : DPL & CTL acceptors and their immediate complications & delayed complications were evaluated in this study. The overall mean age was 24.1 years for both groups. As evident from previous studies (Table 8), the mortality rate for the procedures ranged from In our study the mortality did not exist. The intraoperative major morbidity in DPL was more than the CTL in all studies including this study. It explains the inherent risk of complications with the procedure. A total of 6 cases were recorded as major morbidity in which 2 cases were bowel injuries occurred during placement of trocar.

7 Sudhir Babu & Vijaja Lakshmi / Int J Med Biosci. 2013; 2(1): Previous study Chamberlein G (1972) [4] WHO (1982 ) [5] Letchworth et al.(1980) [6] Meyer JM & King TM (1976) [7] Sitompu et al. (1984) [8] Taner et al. (1994) [9] Present Study ( ) Total no. of cases Major Morbidity Minor Morbidity DPL CTL DPL CTL 29, Table. 8. Corroborative studies of Major and Minor Morbidity They were subsequently repaired by laprotomy without further complications. Another 4 cases were recorded as having intraperitoneal hemorrhage. In those 4 cases, 3 cases were managed conservatively and 1 case underwent laparotomy for omental tear and was sutured. With reference to intra operative major morbidity for CTL, there were 3 cases and 2 cases had bladder injuries and 1 case with intraperitoneal hemorrhage. All these cases were repaired by surgery under anesthesia. The post-operative major morbidity in both groups was equal i.e. 2 cases in each group. Major morbidity for delayed complications was equal in both groups. The cases in both acceptors were ectopic pregnancies. The major morbidity is more in DPL procedure due to the technique itself. The position, creation of pneumo peritoneum and blind insertion of trocar were major risk points in the procedure. The CTL is therefore superior to DPL in terms of major morbidity. Even intra operative minor morbidity is more in DPL acceptors than the CTL acceptors. The cause for increase in morbidity due to technique itself i.e. steep trendelenberg position and peneumoperitoneum. Whereas, post-operative minor morbidity is more in CTL acceptors (12.4) when compared to DPL group. The cause of this is due to increased manipulation of abdominal structures in CTL group which cased post-operative pain and infection. Our study showed that low back ache was the leading complaint (28.9) in the delayed complications. The next delayed complication was white discharge; there is no reason to believe that white discharge should arise after sterilization, as it is such a common complaint in women attending a gynecological clinic. So the incidence of major morbidity for immediate complications was more in DPL group (1.6) when compared to conventional tubectomy group (1). However the incidence of minor morbidity for immediate complications was more in conventional tubectomy group (14.4) compared to DPL group (8). The intra operative major morbidity & minor morbidity was more in DPL acceptors (2.6) compared to conventional tubectomy group (1.2). The post-operative morbidity (0.4) and delayed major morbidity (0.2) were equal in both groups. It shows these complications were more in conventional tubectomy group compared to DPL group. Psychological upsets of minor nature are present in 2.5 of both groups more in conventional tubectomy group (3.4) compared to DPL group (1.6). The leading disorder was depression and the major reason behind this may be morbidity caused by the procedure and predisposed previous state of psychological health. The overall mean percentage for causes of regret was 5.9 more in conventional tubectomy group (8.6) compared to DPL group (3.2). Finally acceptors felt DPL procedure is good compared to in CTL group. This proves overall superiority of DPL procedure over conventional procedure. Conclusion The DPL procedure is clearly at advantage than conventional tubal ligation procedure in terms of complications. The major morbidity is more in DPL acceptors; & minor morbidity is more in conventional tubectomy acceptors. Moreover psychological upsets of minor nature are present in 2.5 of both groups. However, much more population studies are needed in order to confirm this finding.

8 Sudhir Babu & Vijaja Lakshmi / Int J Med Biosci. 2013; 2(1): Conflict of interest statement We declare that we have no conflict of interest. Acknowledgements We sincerely thank all women who gave consent and participated in this study. References [1] International Institute of Population Sciences and ORC Macro. National Family Health Survey - 3. International Institute of Population Sciences, Mumbai. [Last accessed on 2010, Nov 05]..Available [2] National Family Health Survey - 3. International Institute of Population Sciences, Mumbai. [Last accessed on 2011 Sep 27]. Available: 1/India_volume_I_corrected_17oct08.pdf. [3] Jayakrishnan K, Sumeet NB. Laparoscopic tubal sterilization reversal and fertility outcomes. J Hum Reprod Sci. 2011; 4(3): [4] Chamberlain G. A review of gynaecological laparoscopy. Recent advances in Obstetrics & Gynaecology. 13 th Edn [5] WHO. Task force on female sterilization,special programmee of research, development and research training in human reproduction. Randomized comparative study of culdoscopy and minilaparotomy for surgical contraception in women. Contraception 1982; 26(6): [6] Letchworth AT, Kane JL, Noble AD. Laparoscopy or laparotomy for sterilization of women. Obstet Gynecol 1980;56(1): [7] Meyer JH, King TM. In: Advances in Female Sterilisation Techniques. Hagerstown, Maryland, Harper & Row, Publishers. [8] Sitompul H, Lun KC, Lumbanraja M, Kabran RM, Albar E, Simanjuntak P, Hanafiah MJ. Comparison of three types of tubal sterilization: the Medan experience. Contraception 1984;29(1): [9] Taner CE, Aban M, Yilmaz N, Senturk N, Toy E. Pomeroy tubal ligation by laparoscopy and minilaparotomy. Adv Contracep 1994;10: