1. Name of the Candidate Dr.Roji Philip
and Address : 53/Hema,Narayana Guru Hsg.Society,
Chembur,Mumbai-40008
2. Name of the Institution : ST. JOHN’S MEDICAL COLLEGE HOSPITAL
3. Course of study and subject : M.S. GENERAL SURGERY
4. Date of Admission to Course : 16 April, 2008
5. Title of the Topic: THE EFFECTS OF DIFFERENT ABDOMINAL PRESSURES ON PULMONARY FUNCTION IN LAPAROSCOPIC CHOLECYSTECTOMY.
6. Brief resume of the intended work: `
6.1Need for the study
During laparoscopic surgery, the length of the incision is shorter, there is less pain, the patient may be mobilized sooner, and the hospitalization and recovery periods are shorter than open procedure. In addition, there is a quicker return to daily activities and to work.Accordingly, some studies have shown that pulmonary function test results and arterial gas results are affected to a lesser degree during laparoscopic surgery.Further, it has been suggested that this lesser effect on pulmonary function test results and arterial gases is associated with lower rates of postsurgical pulmonary complications.Although, it has been shown that pulmonary dysfunction may develop after laparoscopic cholecystectomy, the effects of a CO2 pneumoperitoneum on pulmonary function test results have not been previously studied much. Therefore, the need to evaluate the effects of laparoscopic cholecystectomies performed with different intra-abdominal pressures on pulmonary function test results
6.2Review of literature
Post operative pulmonary dysfunction is an important problem after Open cholecystectomy(OC)(1).Historically,values of pulmonary function test,when taken on the day after open upper abdominal surgery and cholecystectomy,show decreases of 40%-60% compared with preoperative determinations(2).This has been attributed to division of abdominal muscles,inscisional pain and diaphragmatic dysfunction,which impair the cough reflex,leading to small-airway collapse,and substantial reduction in pulmonary function and hypoxemia.(3,4).Laparoscopic Cholecystectomy(LC) is associated with less marked injury to the abdominal muscles and thus may have lesser effect on pulmonary function(3,5).However CO2 gas used for pneumoperitoneum in LC interferes significantly with pulmonary function(6).Also,the residual gas pockets between the liver and the diaphragm cause pulmonary dysfunction and complications(7,8,9).No standard intra-abdominal pressure range has been defined for laparoscopic cholecystectomy. Laparoscopic cholecystectomy with pneumoperitoneum has generally been performed using 15-mm Hg pressures; however, owing to an understanding of the adverse effects of intra-abdominal pressure and enhanced operative techniques, the procedure is currently performed with 12-mm Hg pressures(range 08-15 mm hg). The long pneumoperitoneum during laparoscopic cholecystectomy may be responsible for increases in pulmonary dysfunction(10).Thus the amount of CO2 used to create pneumoperitoneum which is reflected by abdominal pressures during LC carries great significance with respect to post operative pulmonary morbidity and needs to be studied further.
6.3Objectives of the study
To examine the effects of differing intra-abdominal pressures on the pulmonary function in laparoscopic cholecystectomy.
7. Materials and Methods:
7.1 Source of data
All consecutive patients(18 years and above) with symptomatic gallstone disease admitted to the Department of Surgery atSt. John’s Medical College Hospital for elective laparoscopic cholecystectomy between 1 October 2008 and 30 September 2010 will be prospectively studied.
7.2 Method of collection of data ( including sampling procedure, if any)
Prospective randomized trial
Informed written consent would be obtained from every patient. The study would be performed in accordance with the principles stated in the Declaration of Helsinki, and in conformity with the ICMR guidelines.
The speed with which laparoscopic cholecystectomy has been developed and introduced into routine practice is unprecedented in the history of surgical procedures.However considerable changes in pulmonary function do occur after LC which is related to the use of CO2 for pneumoperitoneum during LC.
INCLUSION CRITERIA:a)Age 18-65 yrs b)Symptomatic gall stones(confirmed ultrasonologically) c)American Society for Anaesthesiology(ASA) class 1 and 2 only.
EXCLUSION CRITERIA:a)Emergency surgery b)Associated choledocholithiasis c)History of previous chronic pulmonary diseases d)Cases converted from LC to OC e)Previous abdominal surgery f)Systemic or connective tissue disorders g)H/O tobacco use h)Abnormal preoperative ventilation parameters[Acc. To American Thoracic Society Criteria]
STEP 1:PREOPERATIVE EVALUATION.
a)Age,Gender,Height,Weight,BMI(body mass index),H/O Smoking,Hypertension&Diabetes.
b)Routine blood investigations
c)Study-specific investigations:1]CHEST X- RAY 2]PULMONARY FUNCTION TESTS(PFT)-using a standard spirometer 3]ARTERIAL OXYGEN SATURATION(SaO2)-using a bedside pulse oximeter.
STEP 2:INTRAOPERATIVE EVALUATION.
a)Surgery will be done under general anaesthesia.Patient should be NPO 8 hrs prior to surgery.
b)Same premedication and anaesthetic protocol will be followed for all patients.
c)For hydration,all patients will be administered sodium chloride(10-15ml/kg/hr IV 0.9%)
d)Electrocardigraphy,peripheral O2 saturation,noninvasive BP monitoring,heart rate and end-tidal CO2 will be monitored.
e)LC will be done using the standard 4-port technique.
f)Pneumoperitoneum will be established with CO2 insuffilation using automatic insuffilators.
g)The pressures created as a result of CO2 insuffilation will be duely noted.eg.13 mm Hg.
d)The patients will be turned to the left at a 10-15 degree reverse Trendelenberg position.
e)At end of operation,gall bladder bed will be washed with 0.9% sodium chloride and aspirated,subhepatic suction drain wil be placed.
f)Umbilical port sheath was closed with ‘00’ proloene;skin was closed with staplers.
g)Adequate and same analgesia will be given postoperatively to all patients as and when required.
h)Patients will receive oxygen supplementation by ventimask postoperatively in the recovery room if required.
i)The duration of the surgery will be noted.
STEP 3:POST-OPERATIVE EVALUATION.
On the morning following surgery,CHEST X-RAY and PFT will be done and SaO2 will be measured by a pulse oximeter.
OUTCOMES MEASURED:
a)CHEST X-RAY:To detect development of atelectasis
b)PFT:Following values will be measured-1]FORCED VITAL CAPACITY(FVC) 2]FORCED EXPIRATORY VOLUME AT 1 SECOND(FEV1) 3]FORCED EXPIRATORY FLOW AT 25%-75%(FEF25%-75%) 4]PEAK EXPIRATORY FLOW RATE(PEFR)
*FEV1/FVC RATIO WILL BE CALCULATED.
c)SaO2:Will be measured as % saturation at room air.
STEP 4:STATISTICAL ANALYSIS OF THE COLLECTED DATA.
Relevant standard statistical analysis will be followed.
7.3 Does the study require any investigations or intervention to be conducted on patients or other humans or animals? If so, please describe briefly.
Radiological examinations,Pulmonary function tests,Laparoscopic Surgery.
7.4 Has ethical clearance been obtained from your institution in case of 7.3
Yes
8. List of References:
1. Cuschieri RJ,Morran CG,Howie JC,Macardle CS.Post operative pain and pulmonary complication:comparison of three analgesic regimens.Br J Surg 1985;72:495-8.
2. Hasukic S,Mesic D,Dizdarevic E,Keser D,Hadziselimovic S,Bazardzanovic M:Pulmonary function after laparoscopic and open cholecystectomy.Surg Endosc 2002;16:163-165.
3. Frazee RC,Roberts JW,Okeson GC,Symmonds RE,Snyder SK,Hendricks JC,et al.Open versus laparoscopic cholecystectomy:a comparison of post operative pulmonary function.Ann Surg 1991;213:651-4.
4. Berggren U,Gordh T,Grama D,Haglund U,Rastad J,Arvidsson D.Laparoscopic versus open cholecystectomy:hospitalization,sick leave,analgesia response.Br J Surg 1994;81:1362-5.
5. Ravimohan M,Lileswar K,Ravul J,Singh R,Jindal R:Post operative pulmonary function in laparoscopic versus open cholecystectomy:a prospective,comparative study.Indian J Gastroenterol 2005;24:6-8.
6. Kum CK,Espasen E,Aljaziri A,Troidl H.Randomised comparison of pulmonary function after the French and American techniques of laparoscopic cholecystectomy.Br J Surg 1996;83:938-41.
7. Jackson SA,Laurence AS,Hill JC.Does post laparoscopy pain relate to residual carbon dioxide?Anaesthesia 1996;51:485-7.
8. Fredman B,Jedeikin R,Olsfanger D,Flor P,Gruzman A.Residual pneumoperitoneum:a cause of post operative pain after laparoscopic cholecystectomy.Anaesthesia Analg 1994;79:152-4.
9. Alexander J,Hull MG.Abdominal pain after laparoscopy:the values of gas drain.Br J Obstet Gynaecol 1987;94:267-9.
10. Karagulle,Erdal MD;Turk,Emin MD;Dogan,Rusina MD+;Ekici,Zuhal MD+;Dogan,Rafi MD++;Gokhan MD.The effects of different abdominal pressures on pulmonary function test results in laparoscopic cholecyctectomy.Surg laparoscopy,endoscopy&percutaneous techniques 18(4):329-333 August 2008.
9. Signature of Candidate:
10. Remarks of the guide:
11. Name and Designation of
11.1 Guide:DR. ANTHONY PRAKASH ROSARIO,
PROFESSOR AND UNIT CHIEF,
SURGERY UNIT 1, ST.JOHN’S MEDICAL COLLEGE HOSPITAL
11.2Signature:
11.3Co-guide (if any) : NA
11.4Signature :
11.5Head of Department: DR. T.K.LAKSHMIKANTH
11.6Signature :
12. 12.1 Remarks of the chairman and principal:
12.2 Signature: